United States Food and Drug Administration: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.Drug Approval: Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.Endpoint Determination: Establishment of the level of a quantifiable effect indicative of a biologic process. The evaluation is frequently to detect the degree of toxic or therapeutic effect.United StatesClinical Trials as Topic: Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.Treatment Outcome: Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.Food: Any substances taken in by the body that provide nourishment.Device Approval: Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.Food Labeling: Use of written, printed, or graphic materials upon or accompanying a food or its container or wrapper. The concept includes ingredients, NUTRITIONAL VALUE, directions, warnings, and other relevant information.Administration, Oral: The giving of drugs, chemicals, or other substances by mouth.Food Supply: The production and movement of food items from point of origin to use or consumption.Equipment Safety: Freedom of equipment from actual or potential hazards.Food Analysis: Measurement and evaluation of the components of substances to be taken as FOOD.Drug Labeling: Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.Food Preferences: The selection of one food over another.Drug Administration Schedule: Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.Elephantiasis, Filarial: Parasitic infestation of the human lymphatic system by WUCHERERIA BANCROFTI or BRUGIA MALAYI. It is also called lymphatic filariasis.Legislation, Food: Laws and regulations concerned with industrial processing and marketing of foods.

*  GMP Regulations and Preambles | ISPE
United States - Food and Drug Administration GMP Regulations. *21 CFR Part 4 - Current Good Manufacturing Practice Requirements ... Canadian Good Manufacturing Practices for Drugs (Part C Division 2 of Food and Drug Regulations) ... Regulations for Implementation of the Drug Administration Law of the People's Republic of China ... Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (Tentative ...
http://ispe.org/gmp-resources/regulations
*  Sangrado menstrual abundante | Medical City Dallas
United States Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ... United States National Library of Medicine, National Institutes of Health website. Available at: http://www.nlm.nih.gov/ . ...
http://medicalcityhospital.com/hl/?/22631/Hipermenorrea/sp&com.dotmarketing.htmlpage.language=1
*  Farm Stops Salad Production Over Cyclospora Stomach Bug Outbreak - ABC News
... states has voluntarily stopped making and shipping bagged salads to the United States until the Food and Drug Administration ... Texas, which has more cases than any other state, has not yet pinpointed which food sickened its citizens. ... Taylor Farms in Mexico has stopped shipping salads to the United States. (Credit: Nati Harnik/AP Photo) ... Taylor Farms in Mexico has not yet been tied to the 296 cyclospora infections in the 16 remaining states, according to the FDA ...
http://abcnews.go.com/blogs/health/2013/08/12/farm-stops-salad-production-over-cyclospora-stomach-bug-outbreak/
*  The role of meta-analysis in the regulatory process for foods, drugs, and...
... formal meta-analysis may substitute for a pivotal study or broaden the generalizability of drug efficacy through a preplanned ... While synthesis is currently required in the US food and drug regulatory process, ... Drug, Device, Methodology, Metaanalysis, Clinical trial, Food and Drug Administration, United States, North America, America, ... Food and Drug Administration, Etats Unis, Am rique du Nord, Am rique, Homme ...
http://bdsp.ehesp.fr/Base/186800/
*  Endo Health Solutions Inc Unit Receives FDA Warning Letter Tied To Form 483...
... the United States Food and Drug Administration (the "FDA") conducted an inspection of the Minnetonka, Minnesota facility of ...
http://biospace.com/News/endo-health-solutions-inc-unit-receives-fda/330368
*  The Media Manipulates Flu Vaccine Facts
In the United States, federal health officials at the Food and Drug Administration (FDA) are in charge of selecting which ... Food Facts. Find out food facts, nutrition facts, and healthy recipes of common healthy foods that you should add to your ... In the United States, the minimum age for the first dose of measles vaccine is recommended as 12 months, but this may actually ... Measles cases have greatly increased in parts of Canada and the United States this year. Although unvaccinated children and
http://articles.mercola.com/sites/articles/archive/2011/12/26/media-deceive-facts-regarding-flu-vaccine.aspx?e_cid=20111226_DNL_art_2
*  Lindsay Rosenwald
Many of these medicines have received approval from the United States Food and Drug Administration, as well as several ... Spotlight on United Faith Church in Barnegat, NJ - Pastor Jerry and Pastor Janeth Santiago's Family ... Below, Lindsay Rosenwald explains how targeted therapy drugs are contributing to advancements in cancer treatment. Aicube: What ... In total, these companies have produced well over 100 licensed clinical-stage drugs. ...
http://aicube.com/author/lindsay-rosenwald/
*  Heparin Use in Deep Venous Thrombosis: Overview, Unfractionated Heparin, Low...
... and tinzaparin have received US Food and Drug Administration (FDA) approval for the treatment of DVT in the United States; ... U.S. Food and Drug Administration. Communication about an Ongoing Safety Review of Innohep (tinzaparin sodium injection). ... Drug therapy should be initiated at the same dose as for nonpregnant patients, but the dose may have to be increased if anti-Xa ... Drug clearance is higher in early pregnancy and trends toward normal at delivery. Therefore, monitoring of anti-Xa ...
http://emedicine.medscape.com/article/1927155-overview
*  Daily Trojan, Vol. 150, No. 25, October 01, 2003 :: University of Southern...
FluMist is the first nasal-spray flu vaccine to be marketed in the United States. It was approved by the Food and Drug ... It was approved by the Food and Drug Administration in June. Healthy people age 5 to 49 can take FluMist, which is manufactured ... FluMist is the first nasal-spray flu vaccine to be marketed in the United States. ... Of interest... Planned state land purchases needlessly deprive funding from other projects / 4 1 aurtn Greenfield's photo ...
http://digitallibrary.usc.edu/cdm/compoundobject/collection/p15799coll104/id/128092/rec/39
*  ADHD drugs: oversold and overused - tribunedigital-baltimoresun
... sneakers and a stimulant medication for attention-deficit hyperactivity disorder.Nearly 2 million children in the United States ... The Food and Drug Administration should move forward with rules to bring the United States into compliance - in conjunction ... Called on the carpet by the U.S. Drug Enforcement Administration, lawyers for the drug companies vowed to defend themselves ... Children in the United States are 10 times more likely to take a stimulant medication for ADHD than are kids in ...
http://articles.baltimoresun.com/2007-08-23/news/0708230108_1_adhd-methylphenidate-psychotropic-medications
*  Fda Regulations
Healthy Living Read More: Fda Regulations, Fda Kind Bars, Kind Snacks, Kind Snack Bars, Kind Bars, Kind Bars Nutrition, Kind Bars Health, Kind Bars Branding, Kind Bars Label, Healthy Living News. Healthy Living Read More: Healthy Living Health News, Medical Ethics, 23andme, Mental Health, Corporate Responsibility, Medical Research, Genetic Testing, Science, Fda Approval, Medical Errors, Corporate Social Responsibility, Information Technology, Business Ethics, Human Rights, Fda Regulations, Genes, Health, Ethics, Genetics, Technology, Medicine, Bioethics, Health Care, Genetic Engineering, Regulation, Fda, Government, Deregulation, Healthy Living News. Healthy Living Read More: Trans Fats Fda, Fda Regulations, Trans Fats, Trans Fat Fda, Partially Hydrogenated Oil, Fda, Fda Trans Fats, Fda Trans Fat, Food for Thought, Saturated Fats, Healthy Living News. Healthy Living Read More: Salt, Food Safety, Partially Hydrogenated Oil, Aspartame, Sodium, Food and Drug Administration, ...
http://huffingtonpost.com/news/fda-regulations/
*  WHO | Regulation of in vitro diagnostic devices
Regulation of in vitro diagnostic devices. Play Store. Blood products and related biologicals. Menu Blood products and related biologicals. Quality and safety. Regulation of in-vitro diagnostic devices. Regulation of in vitro diagnostic devices A single contaminated blood plasma donation can spread infections HIV, hepatitis throughout the world. National Medicinal Regulatory Agencies MRA are responsible for evaluation, control and approval of in vitro diagnostic devices IVD. Evaluation and quality control of in vitro diagnostic devices IVD are essential for. WHO Guidelines for the Preparation, Characterization and Establishment of International and other Biological Reference Standards. WHO Technical Report Series TRS No in press Adopted by ECBS 2004 pdf, 334kb. WHO Consultation on Global Measurement Standards and their use in the in vitro Biological Diagnostic Field. Geneva, Switzerland Jun 2004 pdf, 69kb. WHO Consultation on International Biological Standards for in vitro Diagnostic Procedures. Geneva, ...
http://who.int/bloodproducts/ivd/en/
*  "FDA Regulations for Food, Drugs, Biologics, Cosmetics, and Medical Devices Including IVDs" 2014-08-
... 08. Education & Career "FDA Regulations for Food, Drugs, Biologics, Cosmetics, and Medical Devices Including IVDs". DESCRIPTION Have you ever wondered what regulations are applicable for food, drugs, biologics, cosmetics, medical devices including IVDs in the US. This presentation is intended to help you get familiar with the US regulations governing food, drugs, cosmetics, and medical devices and cosmetics including in vitro diagnostic medical devices IVDs. This presentation will present key regulatory requirements as set out in the US regulations for food, drugs, medical devices including IVDs and cosmetics. In this presentation, an overview of FDA regulations applicable for food, drugs, cosmetics and medical devices including IVDs will be presented. Areas To Be Covered in this Seminar : FDA Laws and Regulations Definitions Label and Labeling Regulatory Requirements Subject to Manufacturers for Food, Drugs, Biologics, ...
http://pr-inside.com/fda-regulations-for-food-drugs-biologics-r4102807.htm
*  FDA Regulation of Mobile Medical Apps | Bob on Medical Device Software
FDA Regulation of Mobile Medical Apps. Bob on Medical Device Software. Bob on Medical Device Software. FDA Regulation of Mobile Medical Apps. September 23, 2013 by Bob in FDA and Medical Devices. Help patients/users self-manage their disease or condition without providing specific treatment suggestions; Provide patients with simple tools to organize and track their health information; Provide easy access to information related to health conditions or treatments; Help patients document, show or communicate potential medical conditions to health care providers; Automate simple tasks for health care providers; or Enable patients or providers to interact with Personal Health Records PHR or Electronic Health Record EHR systems. If a mobile application is considered a medical device it will be classified as such class I general controls, class II special controls in addition to general controls, or class III premarket approval and the manufacturer will be required to follow Quality System regulations which ...
http://rdn-consulting.com/blog/2013/09/23/fda-regulation-of-mobile-medical-apps/
*  United States Food and Drug Administration « CBS Detroit
United States Food and Drug Administration CBS Detroit. Detroit Radio.com. CBS Local Sports. CBS Sports Radio. Tailgate Fan. Atlanta. Baltimore. Boston. Chicago. Cleveland. Connecticut. Dallas. Denver. Houston. Las Vegas. Los Angeles. Miami. Minnesota. New York. Philadelphia. Pittsburgh. Sacramento. San Francisco. Seattle. St Louis. Tampa. Washington. SIGN UP FOR NEWSLETTERS. Sponsored By. CBS 62 26905 West 11 Mile Road Southfield, MI 48033 Station Phone: 248-355-7000 Twitter. Facebook Email / Contact Forms Web Team Community Affairs Local TV Programming Sales Inquiries Technical/Reception Network FAQ/Feedback WWJ-TV is part of the. WWJ Newsradio 950 LISTEN LIVE | TOP NEWS. TRAFFIC. WEATHER. FEATURES. PROMOTIONS. EVENTS Welcome to WWJ Newsradio 950 on CBSDetroit.com. Welcome to WWJ Newsradio 950 Detroit s ONLY all news radio station, with accurate and dependable traffic and weather updates. 97.1 The Ticket Today’s Detroit Sports News. Today’s Weather Forecast. Contests. ...
http://detroit.cbslocal.com/tag/united-states-food-and-drug-administration/page/2/
*  MSAA: Latest
Lemtrada™ Receives FDA Approval for Relapsing Forms of MS November 14, 2014 The United States Food and Drug Administration FDA announced today that Lemtrada™ alemtuzumab has been approved for the long-term treatment of relapsing forms of multiple sclerosis MS. On August 15, 2014, Biogen Idec announced that the United States Food and Drug Administration FDA had approved Plegridy™ peginterferon beta-1a for the long-term treatment of relapsing forms of multiple sclerosis MS. MSC Publishes Professional Consensus Paper on DMTs August 20, 2014 Experts from member organizations of the Multiple Sclerosis Coalition MSC, including the Multiple Sclerosis Association of America MSAA, collaborated to develop and write a paper summarizing the current evidence that supports the FDA-approved disease-modifying therapies DMTs for the long-term treatment of multiple sclerosis MS. December 30, 2013 Lemtrada™ alemtuzumab, formerly Campath did not receive ...
http://mymsaa.org/news-msaa/
*  NJOY Bows in anticipation of FDA regulations : Says no to Minors and Flavours
... New Posts. Today's Posts. NJOY Bows in anticipation of FDA regulations : Says no to Minors and Flavours. 1 Post By Australis. Thread: NJOY Bows in anticipation of FDA regulations : Says no to Minors and Flavours. Bookmark Share. Digg this Thread. Add Thread to del.icio.us. Search Thread. 08-11-12, 03:10 PM. Senior Member. Join Date Nov 2012 Posts 129. NJOY Bows in anticipation of FDA regulations : Says no to Minors and Flavours NJOY Electronic Cigarettes is said to be currently sitting at the top of the e-cigarette market in the US. Recently, NJOY became the first independent electronic cigarette company to support the nationally recognized We Card Program and join its Manufacturers Advisory Council. While there is undoubtedly an adult market for flavored products, it's not a market NJOY believes will exist once the FDA asserts guidance for e-cigs. While pretty much any e-cigarette vendor will not sell to minors, and in some cases even prohibit website access to minors, NJOY are the first to officially ...
http://forums.aussievapers.com/e-cigarette-vaporization-political-media-discussion/7529-njoy-bows-anticipation-fda-regulations-says-no-minors-flavours.html
*  State Food and Drug Administration - Rediff Pages
... rediff.com. FRIENDS. State Food And Drug Administration. All Updates. Info. Rss Followers. State Food and Drug Administration. to get instant updates about 'State Food And Drug Administration' on your MyPage. Meet other similar minded people. All Updates Description: The State Food and Drug Administration SFDA is founded on the basis of the State Drug Administration. The State Food and Drug Administration is directly under the State Council of the People's Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China. On July 10, 2007, Zheng Xiaoyu, the former head of China's State Food And Drug Administration, was executed for taking bribes from various firms in exchange for state licenses related to product ...
http://pages.rediff.com/state-food-and-drug-administration/1148857
*  Heart Disease and Stroke. You're The Cure.: Another Step Forward for FDA Regulation of Tobacco
... Heart Disease and Stroke. You're The Cure. Wednesday, March 18, 2009. Another Step Forward for FDA Regulation of Tobacco. This afternoon, the House Committee on Oversight and Government Reform passed the Family Smoking Prevention and Tobacco Control Act. This legislation would finally give the FDA the authority to regulate tobacco products and marketing. The legislation is now clear for a vote by the full House of Representatives. We are hopeful a House vote will occur in the next few weeks. Just a few weeks ago, we blogged about another committee's passage of this bill. We're thrilled Members of Congress are moving this legislation forward. Heart Disease and Stroke: I am the Cure. at 9:56 PM. Labels: Family Smoking Prevention and Tobacco Control Act, Prevention. 1 comment:. I work every day with children who have asthma and their parents who smoke. March 23, 2009 at 8:04 PM. Post a Comment. The Fitness Integrated with Teaching FIT Kids Act has been re-introduced in the 112th Congress in the House of ...
http://yourethecure.blogspot.com/2009/03/another-step-forward-for-fda-regulation.html
*  HR 1108 - FDA Regulation of Tobacco - Key Vote - Project Vote Smart
... SHARE. Please Help Us. BIO. VOTES. POSITIONS. RATINGS. SPEECHES. FUNDING. Key Votes HR 1108 - FDA Regulation of Tobacco - Key Vote. National Key Votes Paul Ryan voted Nay Passage on this Legislation. Read statements Paul Ryan made in this general time period. Stages Aug. 1, 2008 Senate Bill Sent To Committee. July 30, 2008 House Bill Passed. Feb. 15, 2007 Introduced. Family HR 1108 - FDA Regulation of Tobacco. Issues Business and Consumers. Drugs. Stage Details. Legislation - Bill Sent To Committee Senate - Aug. 1, 2008 Full Bill Text. Legislation - Bill Passed House 326-102 - July 30, 2008 Key vote Title : FDA Regulation of Tobacco Vote Result. Yea Votes. Nay Votes. Vote Smart's Synopsis: Vote to pass a bill that authorizes the Food and Drug Administration FDA to regulate the labeling, ingredient levels, and required disclosures related to tobacco products. Highlights:. Allows the Secretary of Health and Human Services to reduce or eliminate additives, constituents, or other ...
http://votesmart.org/bill/7724/21410/26344/fda-regulation-of-tobacco?flavour=mobile
*  American Assn for Clinical Chemistry | Influence Explorer: Lobbying and Regulations
American Assn for Clinical Chemistry. American Assn for Clinical Chemistry. Lobbying on Behalf of American Assn for Clinical Chemistry. American Assn for Clinical Chemistry. View all lobbying data for American Assn for Clinical Chemistry. Toggle 3 FDA. Toggle 2 FDA. Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Framework for Regulatory Oversight of Laboratory Developed Tests LDTs ; Availability 2011. Toggle 1 FDA. Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability 2011. Center for Devices and Radiological Health 510 k Clearance Process; Institute of Medicine Report: “Medical Devices and the Public’s Health, The FDA 510 k Clearance Process at 35 Years;” Request for Comments 2011. Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical ...
http://influenceexplorer.com/organization/american-assn-for-clinical-chemistry/2a3b4e3f21bb42c79662dc712e89b88c?cycle=2012
*  CFR - Code of Federal Regulations Title 21
... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Food Drug Administration. Follow FDA. Enter Search terms. Food. Drugs. Medical Devices. Radiation-Emitting Products. Vaccines, Blood Biologics. CFR - Code of Federal Regulations Title 21. FDA Home. Medical Devices. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations eCFR. New Search. Help. More About 21CFR. TITLE 21--FOOD AND DRUGS. CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION CONTINUED. PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE Subpart B--Listing of Specific Substances Affirmed as GRAS. 184.1322 Wheat gluten. a Wheat gluten CAS Reg. Wheat gluten is obtained by hydrating wheat flour and mechanically working the sticky mass to separate the wheat gluten from the starch and ...
http://accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1322
*  Browsing HLS Student Papers by Title
... DSpace/Manakin Repository. DASH Home. Harvard Law School HLS Student Papers Browsing HLS Student Papers by Title. Login. Browsing HLS Student Papers by Title. Or enter first few letters:. Sort by: submit date title issue date Order: ascending descending Results: 5 10 20 40 60 80 100. Previous Page Now showing items 165-184 of 594. The Regulation of Human Organs. Criswell, Phillip. Fact or Fiction. Singh, Monica. The Family Smoking Prevention and Tobacco Control Act: An Early Evaluation. Weiner, Stephanie. Food and Drug Law: An Electronic Book of Student Papers, 2010. The FDA amp; The FTC: An Alphabet Soup Regulating The Misbranding Of Food. Gerhart, Nicole. THE FDA AND PLAN B: The Legislative History of the Durham-Humphrey Amendments and the Consideration of Social Harms in the Rx-OTC Switch. FDA and Social Media: The Impact of Social Media on Prescription Drug Advertising. Liu, Kassity Yefei 2011. FDA and the Challenge of Alternative Medicine: Realistic Assessments and ...
http://dash.harvard.edu/handle/1/2788313/browse?rpp=20&order=ASC&sort_by=1&etal=-1&type=title&starts_with=F
*  FDA takes action against Georgia dietary supplement manufacturer
... FDA U.S. Follow FDA. Medical Devices. Radiation-Emitting Products. Vaccines, Blood & Biologics. Animal & Veterinary. Tobacco Products. FDA News Release FDA takes action against Georgia dietary supplement manufacturer Share. A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. BioAnue s products were sold as supplements but were unapproved new drugs because they were marketed as treatments for conditions including cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease, and diabetes, without approval from the FDA, according to the court order. 9, 2012, involving the marketing of the firm s dietary supplements as unapproved new drugs. A follow-up FDA inspection in August 2012 revealed that BioAnue was also manufacturing products that were not in compliance with FDA s current good manufacturing practice requirements ...
http://fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm411390.htm
*  Federal Register | Applications for Food and Drug Administration Approval To Market a New Drug; Post
Federal Register. Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs. Skip to Content. Home. Sections. Money. Environment. World. Science & Technology. Business & Industry. Health & Public Welfare. Amendments to the Commission's Rules of Practice. A Proposed Rule by the Securities and Exchange Commission on. 10/05/2015. SEC is proposing for public comment amendments to update its Rules of Practice. photo by: Securities and Exchange Commission. 1 Dodd-Frank Wall Steet Reform 271 in the last year. Stock & Commodities Trading 504 in the last year. Government Contracts 59 in the last year. Economic Sanctions & Foreign Assets Control 597 in the last year. 19 New Documents In this Issue. 16 Comment Periods Ending Soon. Pipeline Safety: Information Collection Activities. A Notice by the Pipeline and Hazardous Materials Safety Administration on. 10/05/2015. PHMSA invites ...
https://federalregister.gov/articles/2009/07/28/E9-17963/applications-for-food-and-drug-administration-approval-to-market-a-new-drug-postmarketing-reports
*  Federal Register | Applications for Food and Drug Administration Approval To Market a New Drug; Revi
Federal Register. Applications for Food and Drug Administration Approval To Market a New Drug; Revision of Postmarketing Reporting Requirements-Discontinuance. Skip to Content. Home. Sections. Money. Environment. World. Science & Technology. Business & Industry. Health & Public Welfare. Amendments to the Commission's Rules of Practice. A Proposed Rule by the Securities and Exchange Commission on. 10/05/2015. SEC is proposing for public comment amendments to update its Rules of Practice. photo by: Securities and Exchange Commission. 1 Dodd-Frank Wall Steet Reform 271 in the last year. Stock & Commodities Trading 504 in the last year. Government Contracts 59 in the last year. Economic Sanctions & Foreign Assets Control 597 in the last year. 19 New Documents In this Issue. 16 Comment Periods Ending Soon. Pipeline Safety: Information Collection Activities. A Notice by the Pipeline and Hazardous Materials Safety Administration on. 10/05/2015. PHMSA invites comments on certain ...
https://federalregister.gov/articles/2011/12/19/2011-32354/applications-for-food-and-drug-administration-approval-to-market-a-new-drug-revision-of
*  U.S. marshals seize supplements marketed as drugs
marshals seize supplements marketed as drugs. Click to Print. Email this. close. marshals seize supplements marketed as drugs. By Michael Johnsen. At the request of the Food and Drug Administration, U.S. marshals on Thursday seized all dietary supplements manufactured by Syntec because of false claims made about the safety and effectiveness of their supplements in treating a number of diseases. The products manufactured by Syntec are not FDA-approved and a complaint filed in the U.S. District Court for the Western District of Wisconsin alleged that several of Syntec's products are unapproved new drugs that may not be introduced into interstate commerce and are misbranded in violation of the federal Food, Drug and Cosmetic Act. Marketing new drug products without FDA review or approval is dangerous because the products may cause consumers to delay or avoid legitimate treatments, FDA associate commissioner for regulatory affairs Dara Corrigan said. ...
http://drugstorenews.com/print/453906
*  Wild Edibles, Inc. 12/4/07
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links. Food Drug Administration. New York District 158 - 15 Liberty Avenue Jamaica, New York 11433-1034. We inspected your seafood processing facility, Wild Edibles, Inc. We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point HACCP regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 21 CFR 123 110. In accordance with 21 CFR 123.6 g, failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402 a 4 of the Federal Food, Drug, and Cosmetic Act the Act, 21 U.S.C. You may ...
http://fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm269150.htm
*  21 CFR Part 660, Subpart E - Hepatitis B Surface Antigen | US Law | LII / Legal Information Institut
The following are only the Rules published in the Federal Register after the published date of Title 21. GPO FDSys XML. type regulations.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration. Summary The Food and Drug Administration FDA is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. 80 # 64 - Friday, April 3, 2015. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment. GPO FDSys ...
https://law.cornell.edu/cfr/text/21/part-660/subpart-E
*  Occupational Safety and Health Administration Regulations - Bridge Lead Removal and General Site Saf
... ety - FHWA-RD-98-179. U.S. Department of Transportation Federal Highway Administration 1200 New Jersey Avenue, SE Washington, DC 20590 202-366-4000. About. FHWA Organization. Headquarters Offices. Field Offices. Careers. Strategic Plan. Business Opportunities. Staff Directories. Highway History. Programs. Acquisition Management. Civil Rights. Federal Lands Highway. Infrastructure. Innovative Program Delivery. Operations. Planning, Environment, and Realty. Policy. Research, Development Technology. Safety. Browse by Topics. Resources. Core Highway Topics. Federal-Aid Essentials. Publications Statistics. Laws Regulations. Policy Guidance Center. Professional Development. Resource Center. Accessibility Resource Library. FHWA Research Library. Briefing Room. Press Releases. Speeches Testimony. Photos. Videos. Media Contacts. Contact. Search FHWA. Federal Highway Administration Research and Technology Coordinating, Developing, and Delivering Highway Transportation Innovations. This report is an ...
http://fhwa.dot.gov/publications/research/infrastructure/structures/98179/occupat.cfm
*  Patient safety reporting and drug label accuracy missing vital information
... March 10, 2010 Patient safety reporting and drug label accuracy missing vital information March 10, 2010 A Perspective piece in the New England Journal of Medicine calls for change in the way researchers and pharmaceutical companies collect and report adverse symptom information in clinical trials submitted to the Food and Drug Administration FDA , and how the FDA represents this information on drug labels. Basch has found that clinicians - the current responsible party for collecting and reporting symptoms in clinical trials - systematically miss important symptoms and often underestimate the severity of the symptoms they do notice. Basch, who works closely with the FDA and National Cancer Institute on research issues, suggests that patients be given the tools to self-report adverse symptoms in clinical trials and online reporting between clinic visits, which can assist nurses and doctors with symptom management and improve communication. More from Medical Sciences. ...
http://phys.org/news/2010-03-patient-safety-drug-accuracy-vital.html
*  FDA Guidances for Early Human Testing of New Drugs | Cancer Network
FDA Guidances for Early Human Testing of New Drugs. Cancer Network. Cancer Network SearchMedica. Topics: ARS 2015. Breast Cancer. Colorectal Cancer. Leukemia Lymphoma. Lung Cancer. Prostate Cancer. Browse All Topics All Topics ARS 2015 Breast Cancer Colorectal Cancer Leukemia & Lymphoma Lung Cancer Melanoma Prostate Cancer. MAIN MENU Home ONCOLOGY Cancer Management Handbook News Blogs Topics Image IQ Podcasts Conferences. Connect to other sites within the UBM Medica Network. Cancer Network SearchMedica. Topics: ARS 2015. Breast Cancer. Colorectal Cancer. Leukemia Lymphoma. Lung Cancer. Prostate Cancer. Browse All Topics All Topics ARS 2015 Breast Cancer Colorectal Cancer Leukemia & Lymphoma Lung Cancer Melanoma Prostate Cancer. Main menu Home. Topics. MAIN MENU Home ONCOLOGY Cancer Management Handbook News Blogs Topics Image IQ Podcasts Conferences. FDA Guidances for Early Human Testing of New Drugs. FDA Guidances for Early Human Testing of New Drugs. Oncology Journal. The two aim at ...
http://cancernetwork.com/articles/fda-guidances-early-human-testing-new-drugs
*  Diagnostics Analysis & Statistics, July 2015 (p22)
2015-2019 France Diagnostics Market Opportunities: Supplier Shares for Instrument and Reagent Suppliers by Test, Business Environment, Market Structure $ 3 900 Industry report July 2015 by Venture Planning Group. Industries : Diagnostics, Diagnostics, In Vitro Diagnostic, In Vitro Diagnostic Countries : France. 2015-2019 Italy Diagnostics Market Opportunities: Supplier Shares for Instrument and Reagent Suppliers by Test, Business Environment, Market Structure $ 3 900 Industry report July 2015 by Venture Planning Group. Industries : Diagnostics, Diagnostics, In Vitro Diagnostic, In Vitro Diagnostic Countries : Italy. 2015-2019 Spain Diagnostics Market Opportunities: Supplier Shares for Instrument and Reagent Suppliers by Test, Business Environment, Market Structure $ 3 900 Industry report July 2015 by Venture Planning Group. Industries : Diagnostics, Diagnostics, In Vitro Diagnostic, In Vitro Diagnostic Countries : Italy. Industries : Diagnostics, Diagnostics, In Vitro Diagnostic, In Vitro Diagnostic ...
http://reportlinker.com/ci02238-p22/Diagnostics.html/mode/premium
*  FDA Regulations Kill | The Beacon
FDA Regulations Kill. The Beacon. . About Us. About Us Centers. Research Fellows. Authors. Board of Directors. Board of Advisors. Staff. What Others Are Saying About Us. The Alexis De Tocqueville Award. Awards. The Lighthouse Logo. Employment Opportunities. Contact Information. Map and Directions. Finances. Blogs. Blogs The Beacon. MyGovCost News Blog. Issues. Newsroom. Newsroom Commentary Articles. In The News. News Releases. Experts. Multimedia. Multimedia Video. Audio. Events. Events Upcoming and Recent Events. Past Events. Audio and Video. Transcripts. Buy Event Materials. Publications. Publications Books. The Independent Review Quarterly Journal. Policy Reports. The Lighthouse Email Newsletter. Commentary Articles. News Releases. Audio and Visual Programs. The Independent Quarterly Newsletter. Research Articles. Working Papers. Course Adoption Program. Students. Students Summer Seminars. Student Internships. Templeton Fellowships Essay Contest. Independent Scholarship Fund. Store. Store Institute Books. ...
http://blog.independent.org/2014/02/20/fda-regulations-kill/
*  FDA approval process: Understanding what it means for a medical device to be FDA approved or cleared
... - tidewaterreview.com. Digital Membership E-Edition Classifieds Automotive Jobs Real Estate Subscriber Services Place an ad. Classifieds Automotive Jobs Real Estate Rentals Place an ad Advertising rate card Digital Membership. Is FDA approved cellulite-reducing drug OK to use. What does the FDA's blessing of fat-melting Cellulaze, as well as all the other medical devices cleared each month, really mean. The most stringent review process for medical devices is pre-market approval PMA, for high-risk Class 3 devices such as pacemakers, defibrillators and anything life-sustaining or life-threatening. Just 1 percent of devices go to market via PMA, and only these are considered FDA "approved." The vast majority of devices that undergo FDA review are moderate-risk Class 2 devices such as medication pumps and surgical lasers like Cellulaze, granted FDA clearance through a controversial process called 510 k. There's no requirement of clinical testing to determine the safety and effectiveness of 510 k ...
http://tidewaterreview.com/features/health/sc-health-0307-cellulite-treatment-fda-20120307,0,928903.story
*  Federal Register | Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Flint H
If you have ever tried to search our site for Federal Register documents published prior to 1994, you ve realized that there is nothing online from 1936 to 1994. Environmental Protection Agency Dates: This direct final rule will be effective April 1, 2013, unless EPA receives adverse comments by March 4, 2013. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the Federal Register informing the public that the rule will not take effect. Effective Date: 04/01/2013 Comments Close: 03/04/2013 Entry Type: Rule Action: Direct final rule. EPA-R05-OAR-2011-0328 Docket Name Flint Hills Resources Amended Findings and Order Minnesota Public Comments. EPA is approving Minnesota's August 29, 2011, request to revise its sulfur dioxide SO 2 State Implementation Plan SIP for Flint Hills Resources Pine Bend, LLC FHR Pine Bend, in Dakota County. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the Federal Register informing the ...
https://federalregister.gov/articles/2013/01/31/2013-02019/approval-and-promulgation-of-air-quality-implementation-plans-minnesota-flint-hills-resources-pine
*  WEB FEATURE: FDA guidance aims to encourage abuse-deterrent painkillers
... One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday. But in the new draft guidance, the agency explains its current thinking about the studies it said companies should conduct to demonstrate that a given formulation of an opioid drug has abuse-deterrent properties, how the agency will evaluate the studies and what labeling claims may be approved. Studies have indicated that adding abuse-deterrent features can reduce abuse of the opioids that have them, but can also steer drug abusers toward other opioids, legal and illegal. Louis and Nova Southeastern University in Florida, the number of drug abusers who abused OxyContin fell from 35.6% to 12.8% after the introduction of the abuse-deterrent version, while abuse of such ...
http://drugstorenews.com/print/517556?ad=people-in-the-news
*  .. Approval Process for Medical Devices is Faulted in Study .. Comments .. Add Your Comment
Approval Process for Medical Devices is Faulted in Study. March 22nd, 2011. Sources: LA Times, NY Times Subjects: Devices, Regulation. Tweet. More than 70% of all medical devices that have been recalled by the FDA for safety concerns were not subjected to rigorous clinical testing before the agency approved them, according to a new study. The study authors were Diana Zuckerman and Paul Brown from the National Research Center for Women and Families, a consumer group, and Steven Nissen, a cardiologist at Cleveland Clinic. The authors reported that overall, the FDA recalled 113 medical devices between 2005 and 2009. Of these, 21 had been approved on the basis of rigorous clinical trial data. Eighty others had been approved under a less stringent, expedited approval process known as 510K, in which a device maker needs only to show that its new product is substantially similar to one already on the market. An additional 8 devices were exempt from FDA regulations, and 4 more were either counterfeit or classified ...
http://pizaazz.com/2011/03/22/approval-process-for-medical-devices-is-faulted-in-study/
*  Managing Manuare Nutrients at Concentrated Animal Feeding Operations: Draft Guidance| US EPA Managin
managing manuare nutrients at concentrated animal feeding operations draft guidance us epa managing manuare nutrients at concentrated animal feeding operations draft guidance jump to main content water recent additions contact us search all epa this area you are here epa home water online publications managing manuare nutrients at concentrated animal feeding operations draft guidance title index epa number audience type document type keyword index office new publications title keyword all about ordering managing manuare nutrients at concentrated animal feeding operations draft guidance epa number r date of publication january pages audience concerned citizens industry publication comments available from web http www epa gov ost guide cafo pdf pnpguide pdf ntis pb ordering information this manual discusses the applicability and implementation of the proposed effluent limitations guidelines and standards elgs and national pollutant discharge elimination system npdes permit requirements for concentrated animal ...
http://yosemite.epa.gov/water/owrccatalog.nsf/065ca07e299b464685256ce50075c11a/534cd5448918306c85256b0600723edb!OpenDocument
*  CFR - Code of Federal Regulations Title 21
... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Food Drug Administration. Follow FDA. En Espa ol. Enter Search terms. Food. Drugs. Medical Devices. Radiation-Emitting Products. Vaccines, Blood Biologics. Animal Veterinary. Cosmetics. Tobacco Products. CFR - Code of Federal Regulations Title 21. FDA Home. Medical Devices. - The information on this page is current as of April 1 2015. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations eCFR. New Search. Help. More About 21CFR. TITLE 21--FOOD AND DRUGS. CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER H--MEDICAL DEVICES. PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES Subpart F--Therapeutic Devices. 876.5970 Hernia support. A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening ...
http://accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=876.5970
*  Coastal Contacts Inc. 12/11/13
... Skip to main page content. Skip to search. Skip to topics menu. Skip to common links. HHS U.S. Department of Health and Human Services. FDA U.S. Food and Drug Administration Protecting and Promoting Your Health. A to Z Index. Follow FDA. En Español. Search FDA. Submit search. Popular Content. Home. Food. Drugs. Medical Devices. Radiation-Emitting Products. Vaccines, Blood & Biologics. Animal & Veterinary. Cosmetics. Tobacco Products. Inspections, Compliance, Enforcement, and Criminal Investigations. Home. Inspections, Compliance, Enforcement, and Criminal Investigations. Compliance Actions and Activities. Warning Letters. 2013. Coastal Contacts Inc. 12/11/13 Share. Tweet. Linkedin. Pin it. More sharing options. Linkedin. Pin it. Email. Print. Department of Health and Human Services. Public Health Service Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993. December 11, 2013. WARNING LETTER. VIA UNITED PARCEL ...
http://fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm379529.htm
*  Approved Vendor PAIL-SCR-5-W Plastic Pail, White, Cap 5 Gal, With Lid
... Live Chat. FAQ. Quote Request. My Account. Login. Food Service. Hand Tools. Pet Supplies. Power Tools. Shipping Packing. Storage Organization. Brands Top Brands. Honeywell. White Rodgers. All Brands... Search Search. Storage Organization. Storage Pails Buckets. Approved Vendor Plastic Pail, White, Cap 5 Gal, With Lid Model: mpn PAIL-SCR-5-W. SKU: 434742. Average Rating: n/a Approved Vendor PAIL-SCR-5-W Plastic Pail, White, Cap 5 Gal, With Lid. Be the first to write a review. $34.92 USD + 3 Business Day Shipping $9.10 No Longer Available. Specs Item Plastic Pail. Capacity 5 gal. Material High Density Polyethylene. Color White. Standards UN 1H2/Y30, FDA regulation 21CFR177.1520 c 3.1, FDA regulation 21CFR178.3297 e, FDA regulation 21CFR178.3130. Includes Screw Top Lid. Description Plastic Pail, Screw Top, Color White, High Density Polyethylene Material, Dimensions 12 5/8 Dia. x 16 1/16H, Capacity 5 Gal, UN 1H2/Y30, FDA regulation 21CFR177.1520 c 3.1, FDA regulation 21CFR178.3297 e, FDA ...
http://drillspot.com/products/434742/Vestil_PAIL-SCR-5-W_Plastic_Pail
*  Food and Drug Administration Amendments Act of 2007
... legislation name = Food and Drug Administration Amendments Act of 2007 fullname = To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. enacted by = 110th effective date = September 27, 2007 public law url = http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf. title amended = 21 U.S.C.: Food and Drugs. Bush signed the 'Food and Drug Administration Amendments Act of 2007' FDAAA, September 27, 2007. Prescription Drug User Fee Act Medical Device User Fee and Modernization Act MDUFMA Best Pharmaceuticals for Children Act BPCA Pediatric Research Equity Act PREA Priority review to encourage treatments for tropical diseases Reagan-Udall foundation Advisory committee ...
https://en.wikipedia.org/wiki/Food_and_Drug_Administration_Amendments_Act_of_2007
*  Thanks for the support « Brownie Points
By bosoxbrian@tampabay.rr.com on December 13, 2008 1:22 pm - Reply. By juliasrants on December 13, 2008 1:47 pm - Reply. By ellenc on December 13, 2008 4:05 pm - Reply. By ellenc on December 13, 2008 4:08 pm - Reply. By ellenc on December 13, 2008 4:09 pm - Reply. By ellenc on December 13, 2008 4:11 pm - Reply. By oregonfan2 on December 13, 2008 7:24 pm - Reply. We all know January follows the holidays, which is followed by February pitchers and catchers!!. By ellenc on December 14, 2008 8:31 am - Reply. By bosoxbrian@tampabay.rr.com on December 14, 2008 10:03 am - Reply. By bob6k on December 14, 2008 4:21 pm - Reply. By ellenc on December 14, 2008 4:43 pm - Reply. I would love too see Texeria in a Boston uniform but nothing more than a 8 yr. Duquette gave Ramirez that type of deal and perhaps a similar deal with Texeria from the Red Sox again. By bosoxbrian@tampabay.rr.com on December 14, 2008 5:18 pm - Reply. By bosoxbrian@tampabay.rr.com on December 15, 2008 1:39 pm - Reply. By bosoxbrian@tampabay.rr.com ...
http://browniepoints.mlblogs.com/2008/12/13/thanks-for-the-support/?like=1&source=post_flair&_wpnonce=39170bc4ce
*  CFR - Code of Federal Regulations Title 21
... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Food Drug Administration. Follow FDA. En Espa ol. Enter Search terms. Food. Drugs. Medical Devices. Radiation-Emitting Products. Vaccines, Blood Biologics. Animal Veterinary. Cosmetics. Tobacco Products. CFR - Code of Federal Regulations Title 21. FDA Home. Medical Devices. - The information on this page is current as of April 1 2015. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations eCFR. New Search. Help. More About 21CFR. TITLE 21--FOOD AND DRUGS. CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER H--MEDICAL DEVICES. PART 872 -- DENTAL DEVICES Subpart G--Miscellaneous Devices. 872.6650 Massaging pick or tip for oral hygiene. A massaging pick or tip for oral hygiene is a rigid, pointed device intended to be used manually to stimulate and massage the ...
http://accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=872.6650
*  CFR - Code of Federal Regulations Title 21
... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links. Food Drug Administration. Follow FDA. En Espa ol. Enter Search terms. Food. Drugs. Medical Devices. Radiation-Emitting Products. Vaccines, Blood Biologics. Tobacco Products. CFR - Code of Federal Regulations Title 21. FDA Home. Medical Devices. - The information on this page is current as of April 1 2015. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations eCFR. New Search. Help. More About 21CFR. TITLE 21--FOOD AND DRUGS. CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER H--MEDICAL DEVICES. PART 886 -- OPHTHALMIC DEVICES Subpart B--Diagnostic Devices. 886.1840 Simulatan including crossed cylinder. A simulatan including crossed cylinder is a device that is a set of pairs of cylinder lenses that provides various equal plus and minus refractive strengths. ...
http://accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=886.1840
*  .. Poor Sleep Tied to More Drinking, Drug Use by Teens .. Timing of First Period Tied to Women’s
Posted in Consumer Top Story on January 19th, 2015. Timing of First Period Tied to Women’s Later Heart Risk: Study. Posted in Features on December 17th, 2014. Posted in Consumer Top Story on December 17th, 2014. Posted in Features on December 16th, 2014. The brains of obese children have a stronger response to sugar than those of kids with a healthy weight, a new study says. Posted in Consumer Top Story, More News on December 16th, 2014. Posted in Features on December 15th, 2014. Posted in Consumer Top Story, More News on December 15th, 2014. Posted in Features on December 14th, 2014. Memory lapses in people with higher levels of education may be associated with increased stroke risk, researchers report. Posted in Consumer Top Story, More News on December 14th, 2014. Posted in Features on December 13th, 2014. Teens Are Sleep Deprived, Study Finds. Posted in Consumer Top Story, More News on December 13th, 2014. Posted in Features on December 12th, 2014. Posted in Consumer Top Story, More News on December ...
http://feelgoodnatural.com/news/category/top-stories/?currency=CA
*  FDA Finds Violations, Unsanitary Conditions at Juice Plant
... Advertisement. Oil Gas. Safety. Products. Plant Safety Health Equipment. Events. White Papers. Company Directory. Advertisement. Advertisement. FDA Finds Violations, Unsanitary Conditions at Juice Plant. Plant Safety Equipment. Defendants have a long history of violating the Federal Food, Drug, and Cosmetic Act the Act, by failing to comply with current good manufacturing practice cGMP and the juice Hazard Analysis Critical Control Point HACCP regulations. Such violations render Jonlly’s fruit and juice beverages adulterated under the Act because they have been prepared, packed, and held under insanitary conditions. Jonlly’s beverages are also misbranded under the Act because they are labeled in a false or misleading manner, and because they bear nutrient content claims such as “light,” and “no sugar,” without complying with FDA regulations for such claims. Under the consent decree, Jonlly and Mr. Pérez Román agreed to cease all operations until they comply with the Act, and bring their ...
http://chem.info/news/2013/01/fda-finds-violations-unsanitary-conditions-juice-plant?cmpid=related_content
*  Shelf Liners | Bar Supplies | myBoelter
Bar Supplies. Bar Supplies. 2' x 10' Roll Clear Matte Finish Bagged with header card Add to Wishlist. 2' x 10' Roll Black Matte Finish Bagged with header card Add to Wishlist. 2' x 40' Roll Clear Matte Finish Bagged with header card Add to Wishlist. 2' x 40' Roll Black Matte Finish Bagged with header card Add to Wishlist. Roll Provides skid-resistance and high impact absorption Net pattern allows thorough drainage, promoting rapid, fog-free drying helps prevent bacteria growth Resistant to food acids, grease, and detergents Conforms to FDA regulations Texliner is constructed of a firm, resilient plastic Add to Wishlist. Roll Provides skid-resistance and high impact absorption Net pattern allows thorough drainage, promoting rapid, fog-free drying helps prevent bacteria growth Resistant to food acids, grease, and detergents Conforms to FDA regulations Texliner is constructed of a firm, resilient plastic Add to Wishlist. Roll Provides skid-resistance and high impact absorption Net pattern allows ...
http://myboelter.com/bar-supplies/bartending-supplies/shelf-liner.html?limit=96&mode=list
*  U.S. Marshals seize drug products distributed by a Florida company
Marshals seize drug products distributed by a Florida company. Skip to search. Department of Health and Human Services. FDA U.S. Food and Drug Administration Protecting and Promoting Your Health. Follow FDA. Search FDA. Food. Drugs. Medical Devices. Radiation-Emitting Products. Vaccines, Blood & Biologics. Animal & Veterinary. Tobacco Products. News & Events. News & Events. 14, 2013 Media Inquires: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA U.S. Marshals seize drug products distributed by a Florida company FDA acts to protect consumers from dangerous diet products U.S. Food and Drug Administration, today seized tainted dietary supplements from Globe All Wellness, LLC Globe All, in Hollywood, Fla. The company s products are drugs that have not been approved by the FDA for their claimed uses. During inspections of Globe All conducted in October 2012 and February 2013, the FDA also ...
http://fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm339887.htm
*  DailyMed - CLEARLAX- polyethylene glycol 3350 powder, for solution
... Skip to Main Content U.S. National Library of Medicine U.S. National Library of Medicine Report Adverse Events. Recalls. Home. News. DailyMed Announcements. Get RSS News Updates. About Dailymed. Contact Us. Safety Reporting Recalls. Report Adverse Events. FDA Saftey Recalls. FDA Guidances Information. NLM SPL Resources. Download Data. - All Drug Labels. - All Indexing Files. - All Mapping Files. SPL Image Guidelines. Articles Presentations. Application Development Support. Resources. - Web Services. - Mapping Files. Help. DailyMed. All Drugs. Human Drugs. Animal Drugs. More ways to search. Advanced Search. Browse Drug Classes. Label Archives. Tablet/Capsule ID Tool. All Drugs. Human Drugs. Animal Drugs. Home News. DailyMed Announcements. Get RSS News & Updates. Search. Advanced Search. Browse Drug Classes. Labels Archives. Tablet/Capsule ID Tool. FDA Guidances Information NLM SPL Resources. Download Data. All Drug Labels. All Index ...
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee30489a-8683-4403-8f85-76434242663c
*  Dr Reddys Laboratories Inc s Announces the FDA Approval of Fondaparinux Sodium Injection
... Post Jobs. News. Jobs. News. News By Date. Search News. Reddy's Laboratories, Inc. RDY 's Announces the FDA Approval of Fondaparinux Sodium Injection. Reddy’s Laboratories NYSE:RDY - News and Alchemia Limited, Brisbane, Australia ASX:ACL.ax - News announced today that Dr. Reddy’s ANDA for Fondaparinux Sodium Injection, a bioequivalent generic version of Arixtra®*, in the US market on July 11, 2011 by the United States Food & Drug Administration USFDA. Reddy’s and Alchemia. This approval is a major milestone for Alchemia, fondaparinux representing a significant source of potential future income for the Company." The US patents on Arixtra expired in 2002, the year before the drug was launched in the US. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure ...
http://biospace.com/News/dr-reddys-laboratories-inc-s-announces-the-fda/226769
*  U.S. FDA Arginine Hydrochloride Registration
FDA Arginine Hydrochloride Registration. . . -- Choose a language -- English اللغة العربية Deutsch Espa ol Fran ais Italiano Polska Portugu s 中文 日本語 한국어 русский Türk Українське Tiếng Việt. HOME FOOD AND BEVERAGES DRUGS Drug Listing Labeling and Ingredients Reviews Drug Master Files Certificate of Registration COSMETICS MEDICAL DEVICES ELECTRONICS FEES WORLDWIDE OFFICES CONTACT US. Drugs. FDA Active Pharmaceutical Ingredients API. API Examples. FDA Regulations : Arginine Hydrochloride. FDA Requirements : Arginine Hydrochloride Registrar Corp assists Arginine Hydrochloride companies with : FDA Registration Arginine Hydrochloride FDA Listing Arginine Hydrochloride. FDA Label Requirements and Exceptions Arginine ...
http://registrarcorp.com/fda-drugs/api-examples/Arginine_Hydrochloride?lang=en
*  MoveOn Petitions - FDA Approval For Ketamine to Treat CRPS
... MoveOn.org MoveOn.org. Start a petition Manage Petitions. Campaign Tips About. Donate. Petition statement to be delivered to FDA, The United States House of Representatives, and The United States Senate FDA Approval For Ketamine to Treat CRPS Petition by Nancy Cotterman. Sign this petition.
http://petitions.moveon.org/sign/fda-approval-for-ketamine.fb49?source=s.icn.fb&r_by=10243893
*  DailyMed - MENTHOLATUM PAIN RELIEF EXTRA STRENGTH- menthol gel
... Skip to Main Content U.S. National Library of Medicine U.S. National Library of Medicine Report Adverse Events. Recalls. Home. News. DailyMed Announcements. Get RSS News Updates. About Dailymed. Contact Us. Safety Reporting Recalls. Report Adverse Events. FDA Saftey Recalls. FDA Guidances Information. NLM SPL Resources. Download Data. - All Drug Labels. - All Indexing Files. - All Mapping Files. SPL Image Guidelines. Articles Presentations. Application Development Support. Resources. - Web Services. - Mapping Files. Help. DailyMed. All Drugs. Human Drugs. Animal Drugs. More ways to search. Advanced Search. Browse Drug Classes. Label Archives. Tablet/Capsule ID Tool. All Drugs. Human Drugs. Animal Drugs. Home News. DailyMed Announcements. Get RSS News & Updates. Search. Advanced Search. Browse Drug Classes. Labels Archives. Tablet/Capsule ID Tool. FDA Guidances Information NLM SPL Resources. Download Data. All Drug Labels. All Index ...
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=49720
*  DailyMed - EB301AP PAIN RELIEF- menthol spray
... Skip to Main Content U.S. National Library of Medicine U.S. National Library of Medicine Report Adverse Events. Recalls. Home. News. DailyMed Announcements. Get RSS News Updates. About Dailymed. Contact Us. Safety Reporting Recalls. Report Adverse Events. FDA Saftey Recalls. FDA Guidances Information. NLM SPL Resources. Download Data. - All Drug Labels. - All Indexing Files. - All Mapping Files. SPL Image Guidelines. Articles Presentations. Application Development Support. Resources. - Web Services. - Mapping Files. Help. DailyMed. All Drugs. Human Drugs. Animal Drugs. More ways to search. Advanced Search. Browse Drug Classes. Label Archives. Tablet/Capsule ID Tool. All Drugs. Human Drugs. Animal Drugs. Home News. DailyMed Announcements. Get RSS News & Updates. Search. Advanced Search. Browse Drug Classes. Labels Archives. Tablet/Capsule ID Tool. FDA Guidances Information NLM SPL Resources. Download Data. All Drug Labels. All Index ...
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=97131&dictionary=on
*  DailyMed - ASPIRIN 81 MG- aspirin tablet, coated
... Skip to Main Content U.S. National Library of Medicine U.S. National Library of Medicine Report Adverse Events. Recalls. Home. News. DailyMed Announcements. Get RSS News Updates. About Dailymed. Contact Us. Safety Reporting Recalls. Report Adverse Events. FDA Saftey Recalls. FDA Guidances Information. NLM SPL Resources. Download Data. - All Drug Labels. - All Indexing Files. - All Mapping Files. SPL Image Guidelines. Articles Presentations. Application Development Support. Resources. - Web Services. - Mapping Files. Help. DailyMed. All Drugs. Human Drugs. Animal Drugs. More ways to search. Advanced Search. Browse Drug Classes. Label Archives. Tablet/Capsule ID Tool. All Drugs. Human Drugs. Animal Drugs. Home News. DailyMed Announcements. Get RSS News & Updates. Search. Advanced Search. Browse Drug Classes. Labels Archives. Tablet/Capsule ID Tool. FDA Guidances Information NLM SPL Resources. Download Data. All Drug Labels. All Index ...
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b4064039-2345-4227-b83d-54dc13a838d3
*  DailyMed - GOLDEN MEDIUM FOUNDATION SPF 15- titanium dioxide powder
... Skip to Main Content U.S. National Library of Medicine U.S. National Library of Medicine Report Adverse Events. Recalls. Home. News. DailyMed Announcements. Get RSS News Updates. About Dailymed. Contact Us. Safety Reporting Recalls. Report Adverse Events. FDA Saftey Recalls. FDA Guidances Information. NLM SPL Resources. Download Data. - All Drug Labels. - All Indexing Files. - All Mapping Files. SPL Image Guidelines. Articles Presentations. Application Development Support. Resources. - Web Services. - Mapping Files. Help. DailyMed. All Drugs. Human Drugs. Animal Drugs. More ways to search. Advanced Search. Browse Drug Classes. Label Archives. Tablet/Capsule ID Tool. All Drugs. Human Drugs. Animal Drugs. Home News. DailyMed Announcements. Get RSS News & Updates. Search. Advanced Search. Browse Drug Classes. Labels Archives. Tablet/Capsule ID Tool. FDA Guidances Information NLM SPL Resources. Download Data. All Drug Labels. All Index ...
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1035fa28-3a2b-470a-b1aa-7ae0678ff055
*  DailyMed - SHEFFIELD PAIN RELIEF- benzocaine gel
... Skip to Main Content U.S. National Library of Medicine U.S. National Library of Medicine Report Adverse Events. Recalls. Home. News. DailyMed Announcements. Get RSS News Updates. About Dailymed. Contact Us. Safety Reporting Recalls. Report Adverse Events. FDA Saftey Recalls. FDA Guidances Information. NLM SPL Resources. Download Data. - All Drug Labels. - All Indexing Files. - All Mapping Files. SPL Image Guidelines. Articles Presentations. Application Development Support. Resources. - Web Services. - Mapping Files. Help. DailyMed. All Drugs. Human Drugs. Animal Drugs. More ways to search. Advanced Search. Browse Drug Classes. Label Archives. Tablet/Capsule ID Tool. All Drugs. Human Drugs. Animal Drugs. Home News. DailyMed Announcements. Get RSS News & Updates. Search. Advanced Search. Browse Drug Classes. Labels Archives. Tablet/Capsule ID Tool. FDA Guidances Information NLM SPL Resources. Download Data. All Drug Labels. All Index ...
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=85739&dictionary=on
*  DailyMed - PLAK SMACKER- sodium fluoride paste, dentifrice
... Skip to Main Content U.S. National Library of Medicine U.S. National Library of Medicine Report Adverse Events. Recalls. Home. News. DailyMed Announcements. Get RSS News Updates. About Dailymed. Contact Us. Safety Reporting Recalls. Report Adverse Events. FDA Saftey Recalls. FDA Guidances Information. NLM SPL Resources. Download Data. - All Drug Labels. - All Indexing Files. - All Mapping Files. SPL Image Guidelines. Articles Presentations. Application Development Support. Resources. - Web Services. - Mapping Files. Help. DailyMed. All Drugs. Human Drugs. Animal Drugs. More ways to search. Advanced Search. Browse Drug Classes. Label Archives. Tablet/Capsule ID Tool. All Drugs. Human Drugs. Animal Drugs. Home News. DailyMed Announcements. Get RSS News & Updates. Search. Advanced Search. Browse Drug Classes. Labels Archives. Tablet/Capsule ID Tool. FDA Guidances Information NLM SPL Resources. Download Data. All Drug Labels. All Index ...
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0de9d469-1a66-4b40-b7c9-dcfa47e8e244
*  DailyMed - COMFORTCAINE TOPICAL ANESTHETIC- benzocaine gel
... Skip to Main Content U.S. National Library of Medicine U.S. National Library of Medicine Report Adverse Events. Recalls. Home. News. DailyMed Announcements. Get RSS News Updates. About Dailymed. Contact Us. Safety Reporting Recalls. Report Adverse Events. FDA Saftey Recalls. FDA Guidances Information. NLM SPL Resources. Download Data. - All Drug Labels. - All Indexing Files. - All Mapping Files. SPL Image Guidelines. Articles Presentations. Application Development Support. Resources. - Web Services. - Mapping Files. Help. DailyMed. All Drugs. Human Drugs. Animal Drugs. More ways to search. Advanced Search. Browse Drug Classes. Label Archives. Tablet/Capsule ID Tool. All Drugs. Human Drugs. Animal Drugs. Home News. DailyMed Announcements. Get RSS News & Updates. Search. Advanced Search. Browse Drug Classes. Labels Archives. Tablet/Capsule ID Tool. FDA Guidances Information NLM SPL Resources. Download Data. All Drug Labels. All Index ...
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=85228&dictionary=on
*  DailyMed - CITROMA- magnesium citrate liquid
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=100875&dictionary=on
*  DailyMed - PETROLEUM- petrolatum jelly
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff79e42c-da3f-4aec-acf4-cc26e10a1d08
*  DailyMed - SEROTONIN- serotonin hydrochloride liquid
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=110366&dictionary=on
*  DailyMed - AZITHROMYCIN - azithromycin tablet
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84acc7d8-ae0a-4158-a745-3d380afef64c
*  DailyMed - PRAZOSIN HYDROCHLORIDE- prazosin hydrochloride capsule
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ce90aaf-d075-4617-9a47-e8d922096d23
*  DailyMed - FERROUS SULFATE - ferrous sulfate tablet
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=444b2413-b539-4dff-af7f-ef00a56f7c2b
*  DailyMed - PAIN RELIEF 8 HR- acetaminophen tablet, film coated, extended release
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=83217&dictionary=on
*  DailyMed - ACETAMINOPHEN- acetaminophen tablet, film coated, extended release
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=87219&dictionary=on
*  DailyMed - ACETAMINOPHEN- acetaminophen tablet, film coated, extended release
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80310ab1-f10f-4881-b31a-fa156db8e474
*  DailyMed - ACETAMINOPHEN- acetaminophen tablet, film coated, extended release
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe4e9ec5-fa9c-4494-8516-ab477e0fa918
*  DailyMed - MIGRAINE FORMULA- acetaminophen, aspirin and caffeine tablet, coated
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b89784cf-8515-4254-ae4c-eff9b7667620
*  DailyMed - XOLAIR- omalizumab injection, solution
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f6a2191-adfb-48b9-9bfa-0d9920479f0d
*  DailyMed - KETOCONAZOLE- ketoconazole tablet
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=46698e84-8dd2-4faf-aaf0-d7cddfebb71f
*  DailyMed - IBUPROFEN- ibuprofen capsule, liquid filled
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4aea1d82-f763-4b45-9b58-1c2d05ae0481
*  DailyMed - SIMVASTATIN- simvastatin tablet, film coated
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=94162&dictionary=on
*  DailyMed - LEVOFLOXACIN- levofloxacin injection, solution
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ecdf16d6-d9ae-46f3-ac64-752620017c29
*  DailyMed - CITALOPRAM- citalopram hydrobromide tablet
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=104339&dictionary=on
*  DailyMed - VETSULIN- insulin pork injection
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4472644f-edc1-4a4f-8506-888bd8ad895a
*  DailyMed - LISINOPRIL- lisinopril tablet
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=91da743d-69f2-4d52-afbe-2a9deb001867
*  DailyMed - DEXAMETHASONE SOLUTION- dexamethasone solution
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d104df0-1073-4b0a-92f2-5541c3d47917
*  DailyMed - PANTOPRAZOLE SODIUM - pantoprazole sodium tablet, delayed release
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e483f0bc-9aff-46a9-baa2-d4e558c62b57
*  DailyMed - HEPARIN SODIUM - heparin sodium injection, solution
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda3f337-deab-40f3-bc0d-0c08baeb8a2d
*  DailyMed - ACTONEL - risedronate sodium tablet, film coated
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33455&dictionary=on
*  DailyMed - NAPROSYN - naproxen tablet
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=78628&dictionary=on
*  DailyMed - HYDROCHLOROTHIAZIDE- hydrochlorothiazide tablet
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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=78635&dictionary=on
*  DailyMed - IBU- ibuprofen tablet
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*  DailyMed - PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release
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*  DailyMed - ATORVASTATIN CALCIUM- atorvastatin calcium tablet, film coated
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*  DailyMed - AMOXICILLIN- amoxicillin tablet, film coated
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*  DailyMed - METHYLPREDNISOLONE- methylprednisolone tablet
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*  DailyMed - ONDANSETRON- ondansetron tablet, orally disintegrating
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*  DailyMed - NITROSTAT- nitroglycerin tablet
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*  DailyMed - CARE ONE CLEARLAX- polyethylene glycol 3350 powder, for solution
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*  DailyMed - GABAPENTIN - gabapentin capsule
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*  DailyMed - BUTRANS- buprenorphine patch, extended release
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*  DailyMed - MIDAZOLAM HYDROCHLORIDE - midazolam hydrochloride injection
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*  DailyMed - NITROGEN- nitrogen gas
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*  DailyMed - PET ITCH RELIEF PLUS PAIN RELIEVER- benzocaine liquid
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*  DailyMed - OXYGEN - oxygen gas
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*  DailyMed - MORPHINE SULFATE- morphine sulfate injection, solution
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*  DailyMed - OMEPRAZOLE - omeprazole capsule, delayed release
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*  DailyMed - RETIN-A - tretinoin cream RETIN-A - tretinoin gel
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*  DailyMed - A2487-18 PORTEX SINGLE SHOT EPIDURAL - regional anesthesia kit
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*  DailyMed - ALSUMA- sumatriptan injection, solution
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*  DailyMed - A3195-17 CONTINUOUS EPIDURAL 17G TUOHY - regional anesthesia kit
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*  DailyMed - A4005-27 SPINAL 27G WHITACRE - regional anesthesia kit
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*  DailyMed - A2867-17 CONTINUOUS EPIDURAL 17G TUOHY - regional anesthesia kit
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*  DailyMed - PROGESTERONE- progesterone capsule
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*  DailyMed - PROGESTERONE- progesterone capsule
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IontocaineMarketing authorization: Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), finalized by granting of a document also called marketing authorization (MA) (equivalent: product license).Surrogate endpoint: In clinical trials, a surrogate endpoint (or marker) is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. The National Institutes of Health (USA) defines surrogate endnpoint as "a biomarker intended to substitute for a clinical endpoint".List of Parliamentary constituencies in Kent: The ceremonial county of Kent,Community-based clinical trial: Community-based clinical trials are clinical trials conducted directly through doctors and clinics rather than academic research facilities. They are designed to be administered through primary care physicians, community health centers and local outpatient facilities.Banquet Foods: Banquet Foods is a subsidiary of ConAgra Foods that sells various food products, including frozen pre-made entrées, meals, and desserts.Food and Drug Administration Modernization Act of 1997Health claims on food labels: Health claims on food labels are claims by manufacturers of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of developing serious heart conditions.Osmotic controlled-release oral delivery system: OROS (Osmotic [Controlled] Release Oral [Delivery] System) is a controlled release oral drug delivery system in the form of a tablet. The tablet has a rigid water-permeable jacket with one or more laser drilled small holes.Food desert: A food desert is a geographic area where affordable and nutritious food is difficult to obtain, particularly for those without access to an automobile.USDA Defines Food Deserts | American Nutrition Association Some research links food deserts to diet-related health problems and health disparities in affected populations, but this phenomenon has been disputed.Medical device: A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).Summarised from the FDA's definition.Public Health Security and Bioterrorism Preparedness Response Act

(1/1514) U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis.

In August 1997, AmBisome (liposomal amphotericin B, Nexstar, San Dimas, CA) was the first drug approved for the treatment of visceral leishmaniasis by the U.S. Food and Drug Administration. The growing recognition of emerging and reemerging infections warrants that safe and effective agents to treat such infections be readily available in the United States. The following discussion of the data submitted in support of the New Drug Application for AmBisome for the treatment of visceral leishmaniasis shows the breadth of data from clinical trials that can be appropriate to support approval for drugs to treat tropical diseases.  (+info)

(2/1514) Advances in the biological therapy and gene therapy of malignant disease.

Biological and gene therapy of cancer have become important components of clinical cancer research. Advances in this area are based on evidence for the presence of tumor antigens, antitumor immune responses, evasion of host control by tumors, and the recognition of host defense failure in cancer patients. These mechanisms are being corrected or exploited in the development of biological and gene therapy. Over the last decade, 9 biological therapies have received Food and Drug Administration approval, and another 12 appear promising and will likely be approved in the next few years. Our approach to gene therapy has been to allogenize tumors by the direct intratumoral injection of HLA-B7/beta2-microglobulin genes as plasmid DNA in a cationic lipid into patients with malignant melanoma. In four Phase I studies, we found a 36% response by the local injected tumor and a 19% systemic antitumor response. In other cancers, gene transfer, expression, and an intratumoral T-cell response were seen, but no clinical response was seen. A variety of follow-up studies with HLA-B7 and other genes are planned. Evasion of host control is now a major target of gene therapy. Strategies to overcome this include up-regulation of MHC and introduction of cell adhesion molecules into tumor cells, suppression of transforming growth factor and interleukin 10 production by tumor cells, and blockade of the fas ligand-fas interaction between tumor cells and attacking lymphocytes. With these approaches, it seems likely that gene therapy may become the fifth major modality of cancer treatment in the next decade.  (+info)

(3/1514) The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator.

The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose" (Federal Food, Drug, and Cosmetic Act). Conducting a clinical investigation may require an approved IDE application. The US Food and Drug Administration encourages early interaction with the agency through the pre-IDE process during the development of a device or technology and during the preparation of an IDE application. This facilitates approval of the IDE application and progression into the clinical investigation. This paper reviews the terminology and applicability of the IDE regulation and the type of study that requires an IDE application to the Food and Drug Administration. The pre-IDE process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed.  (+info)

(4/1514) Availability of immune globulin intravenous for treatment of immune deficient patients--United States, 1997-1998.

Immune globulin intravenous (IGIV) is a lifesaving treatment for patients with primary immunodeficiency. Since November 1997, a shortage of IGIV has existed in the United States. In 1998, the Food and Drug Administration (FDA) required pharmaceutical companies to increase the frequency of reporting on IGIV distribution from biannually to monthly; in addition, FDA facilitated IGIV distribution and informed clinicians about the ongoing shortage. To assess the impact of the IGIV shortage on patient care, in 1998 the Immune Deficiency Foundation (IDF) surveyed physicians caring for immunodeficient patients about whether they have had difficulty obtaining IGIV, measures they have taken because of the shortage, and the effect of the shortage on their patients. This report summarizes data reported to FDA and data obtained from the IDF survey and provides recommendations for IGIV use during the shortage.  (+info)

(5/1514) Procedure for expediting determinations of antibiotic susceptibility of gram-negative, urinary tract pathogens.

Standardized direct disk diffusion antibiotic susceptibility testing on monomicrobial urine specimens is compared with the Food and Drug Administration method. The direct procedure yields acceptable data and may conserve 24 h in reporting results.  (+info)

(6/1514) Herbal remedies: adverse effects and drug interactions.

A growing number of Americans are using herbal products for preventive and therapeutic purposes. The manufacturers of these products are not required to submit proof of safety and efficacy to the U.S. Food and Drug Administration before marketing. For this reason, the adverse effects and drug interactions associated with herbal remedies are largely unknown. Ginkgo biloba extract, advertised as improving cognitive functioning, has been reported to cause spontaneous bleeding, and it may interact with anticoagulants and antiplatelet agents. St. John's wort, promoted as a treatment for depression, may have monoamine oxidase-inhibiting effects or may cause increased levels of serotonin, dopamine and norepinephrine. Although St. John's wort probably does not interact with foods that contain tyramine, it should not be used with prescription antidepressants. Ephedrine-containing herbal products have been associated with adverse cardiovascular events, seizures and even death. Ginseng, widely used for its purported physical and mental effects, is generally well tolerated, but it has been implicated as a cause of decreased response to warfarin. Physicians must be alert for adverse effects and drug interactions associated with herbal remedies, and they should ask all patients about the use of these products.  (+info)

(7/1514) Modernizing the FDA: an incremental revolution.

The U.S. Food and Drug Administration (FDA) is responsible for protecting consumers from unsafe or ineffective drugs and medical devices. The agency's role is defined by a growing and increasingly complex set of statutes, which reflect Congress's desires, on the one hand, to prevent product hazards and, on the other, to expedite FDA review and approval of promising new medical technologies. Congress's latest attempt to calibrate regulation to achieve these goals, the 1997 Food and Drug Administration Modernization Act, endorses certain of the FDA's own innovations and changes in the agency's ways of doing business.  (+info)

(8/1514) When is a cost-effectiveness claim valid? How much should the FDA care?

Federal law requires the Food and Drug Administration (FDA) to regulate the promotional claims of prescription drugs and certain devices. Standards of evidence for claims of safety and therapeutic efficacy are rigorous because inappropriate product use may place human life at risk. However, equally demanding criteria for claims of cost-effectiveness of marketed technologies seem to be unnecessary because the consequence of error is principally a bad buy rather than patient harm. Concern exists about the validity of cost-effectiveness studies, the potential for bias, standards for the conduct of cost-effectiveness research, and the needs of managed care. The FDA should moderate its role in regulating cost-effectiveness claims of drugs and devices. This would foster information flow to healthcare providers and insurers and protect the FDA concern regarding false or misleading claims of effectiveness. Although the issues are applicable to both devices and drugs, we draw mainly from the field of pharmacoeconomics because this is where most of the policy has developed.  (+info)


America


  • In March of 1996, the Food and Drug Administration (FDA) of the United States of America approved acupuncture as a medical treatment method. (theschoolofmassage.co.uk)
  • Disclaimer: The descriptions and the statements of Pain Away1-2-3l on this page are from manufacturers and/or distributors and have not been evaluated by Chong's Health Care or the Food and Drug Administration of the United States of America. (cljhealth.com)


Centers


  • So far, 535 people have been infected and 32 have been hospitalized with the stomach bug-like illness that's caused by a one-celled parasite and spread through contaminated food, according to the Centers for Disease Control and Prevention. (go.com)
  • The INTRuST Consortium is a group of clinical study centers in the United States funded by a Department of Defense award to advance treatments and medical research in PTSD and traumatic brain injury. (bio-medicine.org)
  • Becoming a Plasma Donor," details the safety and eligibility steps required to become a committed plasma donor at one of the 400-plus U.S. Food and Drug Administration-licensed and International Quality Plasma Program-certified plasma collection centers in the United States. (bio-medicine.org)


USDA


  • When a field of maturing corn or other crops is flooded, it is considered to be contaminated by the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA). (ning.com)


Clinical


  • In total, these companies have produced well over 100 licensed clinical-stage drugs. (aicube.com)


Device


  • The device has been approved by the Food and Drugs Administration in the United States. (lighttherapyaz.com)


addiction


  • So far, 159 countries, including the United States, have agreed to ban consumer-targeted marketing of psychotropic medications - which all these ADHD drugs are - that carry the potential for addiction or dependency. (baltimoresun.com)


pharmacies


  • As a result, drug wholesalers and pharmacies are experiencing progressively worsening shortages of CFC-based albuterol inhalers as manufacturers phase them out. (ncdcr.gov)
  • NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE:FRX) announced today that FETZIMA™ (levomilnacipran ER capsules), is now available in pharmacies throughout the United States. (biospace.com)


humans


  • As a result, the crops cannot enter the food supply of humans or animals. (ning.com)
  • This trial will test the hypothesis that a neurosteroid analog of allopregnanolone will be beneficial in the treatment of PTSD and augment our existing safety database for ganaxolone in humans," stated Gail Farfel, Ph.D., Chief Development and Regulatory Officer of Marinus. (bio-medicine.org)


Holding


  • RALEIGH - United States Attorney George E.B. Holding announced that in federal court here today PHILIP JOE GUYETT, JR., 42, of Simi Valley, California, was sentenced today to 96 months imprisonment for three counts of mail fraud, committed in relation to his recovery and sale of human tissue for medical implantation. (blogspot.com)
  • Commenting on this case, United States Attorney George E.B. Holding stated: "The heinous nature of Mr. Guyett's crimes cannot be overstated, and today's sentence should give others working in industries critical to the public health a clear signal that this type of reckless dishonesty comes with serious consequences. (blogspot.com)


investigation


  • The action of Taylor Farms de Mexico exemplifies the company's cooperation with federal and state officials throughout this ongoing, complicated investigation. (go.com)
  • Investigation of the case was conducted by the Office of Criminal Investigations of the United States Food and Drug Administration. (blogspot.com)


scientific


  • Because of the great demand and scientific research, the US Food and Drug Administration incorporated acupuncture into mainstream medicine in April, 1997. (theschoolofmassage.co.uk)


dose


  • Joint Statement of the North Carolina Medical and Pharmacy Boards Concerning CFC and HFA Albuterol Metered Dose Inhalers The United States Food and Drug Administration has ruled that by December 31, 2008, manufacturers may no longer use chlorofluorocarbon(CFC)-based propellants in prescription drugs for-mulated for inhalation, such as albuterol metered dose inhalers. (ncdcr.gov)
  • On an immunosuppressant regimen based on either tacrolimus or cyclosporine where the dose of immunosuppressant has not been increased at least 2 months before Screening and no new immunosuppressant drugs have been added for at leas 2 months before Screening. (blogspot.com)


take


  • In plain English, here's what that means: let's say you have a study of 200 women, half of whom take a drug and half take a placebo, to examine the effect on breast cancer risk. (mercola.com)
  • Children in the United States are 10 times more likely to take a stimulant medication for ADHD than are kids in Europe. (baltimoresun.com)
  • The trial will take place in the United States and is designed to enroll approximately 120 PTSD patients. (bio-medicine.org)


DEPARTMENT


  • The Food and Drug Administration should move forward with rules to bring the United States into compliance - in conjunction with the Justice Department. (baltimoresun.com)


result


  • Drug companies would argue that increased production and use of ADHD drugs are the result of better diagnosis and treatment. (baltimoresun.com)


currently


  • While synthesis is currently required in the US food and drug regulatory process, formal meta-analysis may substitute for a pivotal study or broaden the generalizability of drug efficacy through a preplanned meta-analysis. (ehesp.fr)
  • PLAINSBORO, N.J., Oct 11, 2004 (PRIMEZONE via COMTEX) -- Integra LifeSciences Holdings Corporation (IART) today announced that Integra LifeSciences has received approval from the United States Food and Drug Administration (FDA) and CE Mark Certification in the European Union from TUV Product Service to sell the terminally sterilized version of its currently-marketed INTEGRA(R) Dermal Regeneration Template in the United States and Europe. (fool.com)


treatment


  • Below, Lindsay Rosenwald explains how targeted therapy drugs are contributing to advancements in cancer treatment. (aicube.com)
  • FETZIMA was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder (MDD), also known as depression, in adults in July 2013. (biospace.com)
  • Completed Phase II epilepsy studies have generated data supportive of the efficacy and safety of ganaxolone in the treatment of both children and adults suffering from refractory epilepsy (patients who continue to have seizures despite taking multiple anticonvulsant drugs). (bio-medicine.org)
  • Dr. Kristian Borg, Professor and Chair, Division of Rehabilitation Medicine, Karolinska Institute, Stockholm, adds, "We have conducted several studies on IvIg treatment in PPS and we have recently been able to characterize subgroups of responders to the drug. (polioplace.org)


study


  • This public-private collaboration will study ganaxolone under Marinus' Investigational New Drug Application (IND) filed with the Food and Drug Administration (FDA). (bio-medicine.org)
  • Principal investigator Dr. Marinos Dalakas, Professor of Neurology at Thomas Jefferson University Hospital, Philadelphia, states: "This is the most promising study ever conducted in PPS because it uses a multi-potent drug that works in many different ways to safely modify the immune system, as has been successfully applied in many different autoimmune neuromuscular diseases. (polioplace.org)
  • Further, this is the only study ever conducted in PPS that examines the long-term effect of such a drug. (polioplace.org)
  • The study is approved by the United States Food and Drug Administration and Health Canada. (polioplace.org)


name


  • Methylphenidate is best known under the trade name Ritalin, which is not among those drugs advertised. (baltimoresun.com)
  • To compare this food to another, enter an food name in the box above and click Search. (skipthepie.org)


percent


  • The United States, the only nation to violate the U.N. treaty, consumes about 85 percent of the stimulants manufactured for ADHD. (baltimoresun.com)
  • The United States has a peanut shortage this fall and soon peanut butter prices will jump around 30 percent . (ning.com)
  • PPTA members produce in excess of 80 percent of the plasma protein therapies used in the United States today and more than 60 percent worldwide. (bio-medicine.org)


people


  • Last year, all four boards worked together to produce and disseminate a brochure designed to inform the public about their work and their service to the people of the state. (ncdcr.gov)


federal


  • Most of the victims were sickened in June, but cases are still being reported to state and federal health departments. (go.com)


great


  • I mean my family all lives in another state so we see one another once in a great while, but say they couldnt fly out it would be nice to have something to go do on the holiday rather than sitting at home by yourself you know? (bayho.com)


available


  • We Believe our formulations are state-of-the-art and the best Alternative Medicines available to you. (bayho.com)
  • You may be aware that xylitol is available for bulk purchases and large quantities may be regularly maintained in your household for your family's baking and food preparation needs. (holidayvet.com)


Page


  • When the results appear, simply click any food and you will see a page comparing this food and the one you clicked on in detail. (skipthepie.org)


serious


  • Marinus is a specialty pharmaceutical company dedicated to the reformulation, development, and commercialization of novel drugs to treat serious neurological and psychiatric disorders. (bio-medicine.org)
  • Heparin-induced thrombocytopenia (HIT) is one of the most serious adverse drug reactions encountered in hospitals ( 1 ). (lww.com)


last


  • Direct-to-parent marketing of ADHD drugs - most of which are stimulants - has grown pervasive over the last few years, despite a United Nations treaty banning most of it. (baltimoresun.com)
  • A report last year by the National Institute on Drug Abuse found that teenage abuse of prescription stimulants was rising. (baltimoresun.com)


cases


  • Darden restaurants include Red Lobster and Olive Garden, but the FDA has only tied Taylor Farms and Darden to the outbreak in two states out of 18 that have reported cases. (go.com)
  • Texas, which has more cases than any other state, has not yet pinpointed which food sickened its citizens. (go.com)
  • In some cases, the drugs are the only thing that keeps a child from being expelled for aggressive behavior, or falling into the foster-care system, or believing that he is an impossibly bad or stupid kid. (baltimoresun.com)


countries


  • Many of these medicines have received approval from the United States Food and Drug Administration, as well as several countries across the globe. (aicube.com)
  • Other countries use the unit kilojoule (kJ) to measure Food Energy. (skipthepie.org)


appear


  • Though the drugs do not appear to be habit-forming in children with ADHD, there's a rising black market for methylphenidate and similar drugs. (baltimoresun.com)


treat


  • The products and the claims made about specific products on or through this site have not been evaluated by United States Food and Drug Administration and are not approved to diagnose, treat, cure or prevent disease. (bayho.com)


companies


  • Called on the carpet by the U.S. Drug Enforcement Administration, lawyers for the drug companies vowed to defend themselves under the umbrella of First Amendment speech rights. (baltimoresun.com)


issue


  • But in 2001, one company began buying ads in the September issue of women's magazines in the United States to draw attention to Metadate CD, a long-acting form of methylphenidate. (baltimoresun.com)


Texas


  • Though not as bad as Texas, dry weather affected farmers in the state with the nation's biggest peanut crop, Georgia. (ning.com)


medical


  • As previously reported in Endo Health Solutions Inc.'s Form 10-K filed with the SEC on March 3, 2014, in February 2014, the United States Food and Drug Administration (the "FDA") conducted an inspection of the Minnetonka, Minnesota facility of American Medical Systems, Inc. ("AMS"), a subsidiary of Endo International plc (Nasdaq: ENDP). (biospace.com)
  • Mr. Guyett, acting through the corporate identity "Donor Referral Services, Inc.," recovered human tissue from deceased individuals at funeral homes in and around the Eastern District of North Carolina and sold such tissue to various tissue banks for subsequent sale to medical facilities for the eventual implantation in medical patients throughout the United States. (blogspot.com)
  • Food and Drug Administration regulations require that certain medical information of the deceased tissue-donor be collected and analyzed by the tissue harvester, as certain medical conditions of the deceased would preclude their tissue from being used for implantation in medical patients. (blogspot.com)


What are some similar foods in the United States that are similar to Singapore foods?


  • I'm doing a recipe on a different culture, besides mine. But I don't really find anything very appetizing so I want something similar to the United States food.
  • Pizza


What is the strangest food you have ever eaten?


  • I love snails,turtle,frog and crickets(as long as they are cooked right) but most people tell me A: I'm a horrible person for eating turtle and frog B: EWWWWW! But I live in the United States so food isn't all that diverse. So what is the strangest food you have eaten and where did you eat it and did you find it yourself like I did with frogs and turtles?
  • Shirako (Fish Sperm) which is a popular dish in Japan.


How is being a food server different in the United States than in Britain?


  • How is the art of serving executed in the United States vs anywhere else, say Britain for example? Is the food served from left to right? Order taken from left to right? How is everything done?
  • I think we have more etiquette rules in the UK, as the first answer indicates, but we aren't as enthusiastic, I do mystery shopping, and am often asked to comment on phrases fast food servers are meant to say, but frankly, if someone in McDonald's said to me, OH good choice the fries are good and hot today, I would back away from them and try not to make eye contact, but if an American said that i would just eye them suspiciously and say GOOD! English people do not like to be over engaged like that, polite unobtrusive, efficient service is most appreciated here.


Where can I buy food from Paraguay in the United States?


  • I would like to find food and ingredients from Paraguay in the United States. Please, let me know of stores or web sites.
  • what type of food are you looking for exactly? It may be very difficult to find such a specialized market in the US or online, you may try markets or websites that specialize in broader south american cuisines. You will find better luck.


What can the United States do to decrease the percentage of Obese people in the United States?


  • I need three main points to help societies in the United States lose weight....such as putting tax on junk foods so not that many people can buy so much, therefore there will become less obese people.
  • Where there is a will there is a way. People will go to great lengths to stay obese because they can get Disability/ medicaid, food stamps etc... that is what we have to stop, the Get Out of Jail Free option. People do this to them selves, some are genetically pre-disposed, but ultimately, with their diet and lack of exercise they continue what their family started and pass it on.


How many vegetarians are there in the United States?


  • I would like to know the population of vegetarians in the United States because I think the Food Network really needs a vegetarian cooking show because as a vegetarian and a huge fan of Food Network I think it would be brilliant.
  • It's estimated that 1% of the US population is vegan and 2.5% are vegetarian. This number has increased as the population has increased. By this (I think) reasonable and even low estimate, with the current population of the US at 300 million, that would mean 7 and 1/2 million vegetarians and around 3 million vegans. Cool! That is a significant minority. Plenty to warrant a veggie cooking show on Food Network. Oh, and let me recommend a veggie cooking show that already exists: The Post Punk Kitchen (www.theppk.com) They have great cookbooks and an awesome website with forums and everything!


What kind of certification does a fromagerie require in the United States?


  • Where can I find information about regulations and required certifications to start a fromagerie (cheese factory) in the United States? I imagine the FDA has something to say about it but I have been unable to find any information online. Can anyone point me in the right direction? Thanks
  • The FDA is the Food and Drug Administration, and I may not be correct, but I think of them when something entirely new is introduced and needs to be certified as being safe to consume. I suppose they are also regulatory, meaning, if you say that you only use 2% milk fat in your product, you better not be using whole milk. I'd check in with the USDA, United States Dept. of Agriculture at USDA.gov As a matter of fact, you can probably put 'dot' gov after any government agency, and find what you're looking for. Another resource is to simply visit a fromagerie here. Someone who has survived the process can better answer your questions in this regard.


Cloned foods in the United States: How do you feel about it?


  • Does anyone else find it I find it ironic that the United States has considered cloning and stem cell research unethical; yet the FDA has no problem providing the citizens of this country with cloned products. It's not ok to research it, yet it's ok to eat it? Is that what I'm getting? How do you guys feel about the FDA's statement to release cloned food products into our country's food supply? I should be more clear on that: not necessarily the US's position, but Bush's.
  • The USDA,FDA,EPA all have lobbyists for the meat industry.They protect the industry,not the consumer.Just to let you know,the USDA tests less than 1% of the animals killed for food.Alisa Harrison was the spokesperson for the National Cattleman's Beef Association for fifteen years,she is now the working for the USDA as a high up secretary. The FDA's draft assesment to approve cloned meat and milk relied heavily on research carried out by Cyagra and Viagen,two big animal cloning companies.That is like tobacco companies trying to tell you that cigarettes are safe,it wasn't even carried out by a third party study. It is has been found that 60% of the public does not want to eat from cloned animals,yet the FDA has stated that it cannot require labeling.This situaion has already happened before,in 1995 the Bush Administration approved for the sale of genetically modified foods for human consumption,it didn't not require labeling either.Why?Their reason was that no one would buy it if they knew.That just goes to show you that they are protecting the industry,not the consumers.I'm really not shocked by this,but many people don't about the industry or where their food comes from. ~The USDA Food Guide Pyramid available through 2005 recommended that meat, poultry, fish, and eggs comprise 14% of the diet, yet 52% of USDA food promotion resources were allocated to these foods. The Pyramid said 33% of the diet should come from fruits and vegetables — which received only 5% of the USDA promotion budget. --Produce for Better Health Foundation ~France,which only has a fraction of the U.S. cattle population,has tested more cattle in a single week than the U.S. tested in an entire decade! ~According to Europe's latest annual report,it is testing at a rate 2,000 times that of the U.S.