United States Food and Drug Administration

Drug Approval

Endpoint Determination

United States

Clinical Trials as Topic

Treatment Outcome

Food

Device Approval

Food Labeling

Administration, Oral

Food Supply

Equipment Safety

Food Analysis

Drug Labeling

Food Preferences

Drug Administration Schedule

Elephantiasis, Filarial

Legislation, Food

Lilly and Company1

• Elizabeth (Nicki) Bush is Senior Advisor and Head of the Patient-Focused Outcomes Center of Expertise at Eli Lilly and Company, responsible for the design and implementation of patient-centered measurement strategies to support drug development efforts across Lilly's portfolio. (isoqol.org)

World Health Organ1

• The Food and Agriculture Organization of the United States and the World Health Organization define probiotics as live microorganisms that, when ingested in an adequate amount, confer health benefit on the host. (medscape.com)

Regulates2

• The Center for Devices and Radiological Health at the Food and Drug Administration (FDA) regulates contact lenses as medical devices, and certain adverse events related to contact lenses are reported to FDA's Medical Device Report (MDR) database. (cdc.gov)
• Of the 20,000 drugs the FDA regulates, mifepristone is the only one that the FDA requires patients to pick up in person at a health center even though they may take it later at a time and place of their choosing. (aclu.org)

Environmental Protec1

• The Environmental Protection Agency states that Teflon does not contain PFOA so the cookware poses no danger. (medlineplus.gov)

20203

• CDC recommendations for hepatitis C screening among adults-United States, 2020. (cdc.gov)
• In 2020, because of the changing epidemiology of HCV infections in the United States, CDC expanded previous risk-based testing recommendations to include universal screening for all adults aged ≥18 years at least once and for all pregnant persons during each pregnancy ( 12 ). (cdc.gov)
• 2020-06-22 State Design Data, Adult State Identifier Data and Youth/Parent State Identifier Data for Waves 2-4 were added to the collection and the State Identifier Restricted Use File User Guide was updated. (umich.edu)

Infections2

• During 2010-2021, hepatitis C virus (HCV) acute and chronic infections (hereinafter referred to as HCV infections) increased in the United States, consequences of which include cirrhosis, liver cancer, and death. (cdc.gov)
• Rates of HCV acute and chronic infections (referred hereinafter as HCV infections) have been steadily increasing in the United States since 2010, with rates of acute infections more than tripling among reproductive-aged persons as of 2021, from 0.8 to 2.5 per 100,000 population among persons aged 20-29 years and from 0.6 to 3.5 among persons aged 30-39 years ( 4 , 5 ). (cdc.gov)

Organization1

• A .gov website belongs to an official government organization in the United States. (medlineplus.gov)

India2

• With today's verdict, the defendant is held accountable for having a hand in every aspect of his pill mill, from the importing of unapproved medications from India, to personally filling orders for these drugs for customers throughout the country. (justice.gov)
• The evidence at trial proved that between May 2018 and August 2019, Kamaldoss participated with others in a transnational drug-trafficking conspiracy, which involved the importation of misbranded prescription drugs, including Tramadol, a synthetic opioid, into the United States from India, re-packaging the drugs at a pill mill operating out of a warehouse in Jamaica, Queens, and shipping the drugs via United States mail to customers throughout the United States. (justice.gov)

Authority1

• The meeting facilitated by WHO under the platform of the African Vaccine Regulatory Forum (AVAREF) was attended by 60 expert representatives of the Ethics Committee and the Pharmacy Board of Sierra Leone with support from Ghana's Food and Drug Authority (GFDA), Health Canada, the European Medicines Agency, the Medicines and Healthcare Products Regulatory Agency (MHRA) United Kingdom, and the United States Food and Drug Administration (US FDA). (who.int)

Pharmaceuticals1

• Parabens, a group of alkyl (e.g., methyl, ethyl, propyl, butyl) esters of p-hydroxybenzoic acid, are widely used as antimicrobial preservatives in personal care products, and can also be used in pharmaceuticals, as well as in food and beverage processing. (cdc.gov)

Persons3

• Curative direct-acting antiviral therapy is approved by the Food and Drug Administration for persons aged ≥3 years. (cdc.gov)
• Approximately 41 million persons in the United States wear contact lenses, a safe and effective form of vision correction if worn and cared for as directed. (cdc.gov)
• Rare diseases are those defined as having a prevalence of no more than 200,000 persons in the United States. (icoatmedical.com)

Attorney4

• Breon Peace, United States Attorney for the Eastern District of New York, announced the verdict. (justice.gov)
• He lined his pockets off the black-market sales of millions of illegal opioids and misbranded prescription pills without regard for the harm caused by the abuse of these highly addictive and dangerous drugs," stated United States Attorney Peace. (justice.gov)
• Preet Bharara, the United States Attorney for the Southern District of New York, announced today the conviction of ROBERT SMUTEK on four counts of distributing and possessing with intent to distribute 1,4 butanediol, an illegal analogue of the date rape drug gamma hydroxybutyric acid, or GHB. (fda.gov)
• U.S. Attorney Preet Bharara said: "Robert Smutek was a modern-day drug dealer, dealing a date rape drug over the Internet out of his suburban home. (fda.gov)

Approval4

• On May 2, 2005, a new in vitro test, QuantiFERON ® -TB Gold (QFT-G, manufactured by Cellestis Limited, Carnegie, Victoria, Australia), received final approval from the U.S. Food and Drug Administration (FDA) as an aid in diagnosing Mycobacterium tuberculosis infection, including both latent tuberculosis infection (LTBI) and tuberculosis (TB) disease. (cdc.gov)
• And the studies that researchers have conducted are not of the magnitude the FDA would require for a drug approval. (healthyplace.com)
• An Italian firm developed it as a pharmaceutical in the early 1970s but lacked the will or the resources to make a run at a drug approval in the United States. (healthyplace.com)
• The United States Food and Drug Administration (FDA) has put forward an approval pathway for AI-based software as a medical device (AI-SaMD). (nature.com)

Humans2

• Meat refers to the flesh of an animal that humans eat as food. (thefreemanonline.org)
• Smallpox only naturally infects humans and does not exist in a carrier state. (medscape.com)

Prevalence2

• With differing rates of diagnosis across countries, states within countries, races, and ethnicities, some suspect factors other than the presence of the symptoms of ADHD are playing a role in diagnosis, [2] although the prevalence of ADHD is consistent internationally. (wikipedia.org)
• [11] The guidelines go on to state that the prevalence drops to 1.5% when using the stricter criteria for the ICD-10 diagnosis of hyperkinetic disorder , used mainly in Europe. (wikipedia.org)

Diagnosis1

• [4] [5] In 2009, the National Institute for Health and Care Excellence, while acknowledging the controversy, states that the current treatments and methods of diagnosis are based on the dominant view of the academic literature. (wikipedia.org)

Clinical Trials1

• Safety requirements for the first use of new drugs and diagnostic agents in man : a review of safety issues in early clinical trials of drugs. (who.int)

Aspirin1

• Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.4 ). (nih.gov)

Additionally1

• Additionally, Kamaldoss conspired to launder the proceeds of the drug-trafficking operation by using the illicit profits to reinvest in the business, including by paying shipping costs incurred by his co-conspirators-including nearly $200,000 in Federal Express costs paid off in exchange for additional pills. (justice.gov)

Tobacco2

• 2021-02-23 Wave 5 Adult and Youth Questionnaire and Weight data files were added to the collection along with Wave 5 Adult and Youth/Parent State Identifier Data and Wave 5 Adult Tobacco Universal Product Code (UPC) Data. (umich.edu)
• The Restricted Use Files User Guide, State Identifier Restricted Use Files User Guide, and Tobacco UPC Data Restricted Use Files User Guide were updated. (umich.edu)

Continually1

• Our bodies make SAMe from methionine, an amino acid found in protein-rich foods, then continually recycle it. (healthyplace.com)

Pharmacology1

• Drug bioscreening : drug evaluation techniques in pharmacology / Emmanuel B. Thompson. (who.int)

Therapeutic2

• The U.S. Food and Drug Administration grants Orphan Drug Designation to drugs intended for the treatment of life threatening or chronically debilitating rare diseases where no therapeutic options are either authorized or where the drugs will be of significant benefit to those affected by the condition. (icoatmedical.com)
• It may take several weeks for the medication to accrue in your system in order to feel the therapeutic effects of this drug. (goodtherapy.org)

Treatments1

• There are safer and probably more effective methods, drugs, or alternative treatments for relieving anxiety and promoting sleep. (msdmanuals.com)

Intensive1

• There is evidence that probiotics should potentially be avoided in patients at higher risk for infection , such as those with indwelling lines, in the intensive care unit, or in immunocompromised states. (medscape.com)

Office3

• NAL's Food Safety Research Information Office (FSRIO) maintains the Research Projects Database (RPD). (usda.gov)
• Elektra Papadopoulos, MD MPH, serves as the Acting Deputy Director of the Division of Clinical Outcome Assessment in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) at FDA. (isoqol.org)
• Mr. Bharara praised the work of the Rhode Island Task Force of the Office of Criminal Investigations, Food & Drug Administration. (fda.gov)

Infection3

• increases in infection rates have corresponded to increases in injection drug use(IDU) ( 8 - 11 ). (cdc.gov)
• The performance of QFT-G in certain populations targeted by TB control programs in the United States for finding latent TB infection is under study. (cdc.gov)
• The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations External (EUA) ( http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm External ) for several diagnostic assays to detect Zika virus infection (2). (cdc.gov)

Workers2

• This report is aimed at public health officials, health-care providers, and laboratory workers with responsibility for TB control activities in the United States. (cdc.gov)
• Trump's visit comes just one day after President Biden briefly chatted with United Auto Workers union boss Shawn Fain before spending 15 minutes addressing workers on the picket line. (whatreallyhappened.com)

Pleaded guilty1

• Navaratnarajah pleaded guilty in June 2022 to the drug conspiracy charges and is awaiting sentencing. (justice.gov)

Agency1

• The Food and Drug Administration (FDA) is an agency of the United States. (thefreemanonline.org)

Control1

• AUD is a chronic and often relapsing disease that may involve compulsive alcohol use, loss of control over drinking, and a negative emotional state when a person is not drinking. (medicalnewstoday.com)

Studies3

• The designation provides development and commercial incentives, including seven years of market exclusivity, protocol assistance on the development of the drug, including clinical studies, and certain exemptions from or reductions in regulatory fees. (icoatmedical.com)
• Data supporting the use of probiotics in this indication come from studies outside the United States and Canada, whereas two high-quality studies performed in those countries have shown no benefit. (medscape.com)
• Evaluation of the vaccine regimen commenced with Phase I clinical trial at the Oxford Vaccine Group in December 2014 and this has been followed by Phase 1 studies in the United States (US) and Africa (Kenya, Uganda, Tanzania). (who.int)

Liver1

• Some people in both Europe and the United States who have taken kava developed liver toxicity (including liver failure). (msdmanuals.com)

Health5

• Despite clear evidence and warnings from its own infectious disease experts that the pandemic is worsening, the Trump administration filed a new motion on Oct. 30 arguing that abortion patients should again be forced to travel unnecessarily to a health center because the risks and burdens of COVID-19 have all been "removed or significantly mitigated. (aclu.org)
• While medication may help a person find relief from debilitating symptoms, drugs do not teach a person to cope in healthy ways when emotions , behaviors, or thoughts are triggered by mental health conditions. (goodtherapy.org)
• Concerns over potential health risks of BPA have led to restrictions on the use of BPA in certain baby and children products (U.S. Food and Drug Administration 2014). (cdc.gov)
• Please contact your state or local health department to facilitate testing. (cdc.gov)
• It has to promote public health and ensure that all human and veterinary drugs and. (thefreemanonline.org)

Kingdom1

• Setting Seven Canadian provinces and two databases in the United Kingdom and the United States. (bmj.com)

Maryland1

• WASHINGTON - Rejecting new arguments from the Trump administration that COVID-19 no longer presents a serious threat, the U.S. District Court for the District of Maryland upheld today its earlier decision blocking a U.S. Food and Drug Administration (FDA) policy that needlessly endangers abortion patients during the pandemic. (aclu.org)

Medications1

• The United States Food and Drug Administration (FDA) has approved three medications for AUD. (medicalnewstoday.com)

Time2

• Over time, these coatings can break down and allow copper to dissolve in food. (medlineplus.gov)
• It's past time the outgoing administration accept defeat-and the FDA turn its attention to a long overdue, comprehensive review of its unnecessary and harmful restrictions on this safe medication used for abortion and miscarriage care. (aclu.org)

Treatment1

• Are there ways to get more out of my treatment with this drug? (goodtherapy.org)

Years2

• She's now off those drugs and feeling more nimble than she has in 20 years. (healthyplace.com)
• Despite his bucolic surroundings, Smutek was as much a drug dealer as those who sell on street corners, and he will now face the consequences of running a narcotics enterprise for more than five years. (fda.gov)

Safety3

• We are thankful the court came through today, but it is outrageous that the Trump Administration thinks this common-sense safety issue should still be up for debate. (aclu.org)
• The RPD tracks food safety research projects funded by FSRIO partner agencies. (usda.gov)
• Thus, the Food and Drug Administration (FDA) has required a warning label on kava products, and safety is under continuing surveillance. (msdmanuals.com)

Include1

• The routes of human exposure to these compounds include industrial pollution, pesticide use, food consumption, and use of personal care products. (cdc.gov)

Study1

• She also leads CDER's COA Drug Development Tool Qualification Program, which includes innovative assessment methods for use as study endpoints. (isoqol.org)

Prescription1

• Intervention A dispensing event was new if no cholesterol lowering drug or niacin prescription was dispensed in the previous year. (bmj.com)

Methods1

• Two IGRAs have been approved by FDA for use in the United States: the original QuantiFERON ® -TB test (QFT) and the recently approved QFT-G. The two tests use different antigens to stimulate IFN-g release, different methods of measurement, and different approaches to test interpretation. (cdc.gov)

York1

• Nous avons mené une étude transversale composée d'observations sur site et d'entretiens structurés de visu dans des commerces situés à New York, Abu Dhabi et Dubaï, identifiés au moyen de recherches sur Google, Yelp, Timeout Dubai et Timeout Abu Dhabi, et de visites de voisinage en 2014. (who.int)

Dealer1

• The defendant is now a convicted drug dealer. (justice.gov)

Network1

• Right Side Broadcasting Network anchor Brian Glenn was stunned by the turnout, stating that attendance had far exceeded expectations for what was thought to be a "small" event. (whatreallyhappened.com)

Found1

• Compounds of lead are usually found in the +2 oxidation state rather than the +4 state common with lighter members of the carbon group . (wikiversity.org)

Hold3

• Pots, pans, and other tools used in cooking often do more than just hold the food. (medlineplus.gov)
• There should be no cracks or rough edges that can trap or hold food or bacteria. (medlineplus.gov)
• Some ceramic cookware should not be used to hold food. (medlineplus.gov)

Result1

• As a result, it may decrease the benefit of levodopa , a drug used to treat Parkinson disease. (msdmanuals.com)

Daily1

• Recommended dose: 50 mg once daily with or without food ( 2.1 ). (nih.gov)