*  Non-publication of large randomized clinical trials: cross sectional analysis | The BMJ
Trial has at least one US site; or trial is conducted under an FDA investigational new drug application or investigational ... Involves a drug, biological product, or device regulated by the Food and Drug Administration ... Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. ... Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of ...
  https://www.bmj.com/content/347/bmj.f6104?tab=response-form
*  Regulatory Strategy and Submissions - NSF International
Review and preparation of Investigational New Drug (IND), New Drug Application (NDA), Biological Application License (BLA), ... as a pre-Investigational New Drug (pre-IND) with the same drug substance, but with other indications using other routes of ... Abbreviated New Drug Application (ANDA) and lifecycle management submissions, such as prior-approval supplements (PAS), all ... agent for pharmaceutical and biotechnology drug applications.. Our experts possess comprehensive knowledge of the regulatory ...
  http://www.nsf.org/services/by-industry/pharma-biotech/pharma-regulatory-strategy-submissions
*  SRI International Executives Discuss Drug Discovery & Development at BioJapan 2009 | SRI International
... from initial discoveries to investigational new drug applications to start human clinical trials. ... leads a unique team of more than 200 people with all the resources necessary to take chemical and biological research programs ... and drug delivery systems. They will explain how SRI's Idea to IND™ approach drives an innovative drug discovery program with a ... SRI International Executives Discuss Drug Discovery & Development at BioJapan 2009. WHAT: A luncheon seminar will focus on SRI ...
  https://www.sri.com/newsroom/press-releases/sri-international-executives-discuss-drug-discovery-development-biojapan-200
*  Promising Cancer Therapeutics Developed by SRI International | SRI International
... from initial discovery to investigational new drug applications to start human clinical trials. SRI Biosciences is a unique ... Biosciences Division is an organization of approximately 200 people with all of the resources necessary to take biological and ... SRI has helped advance on the order of 100 drugs into clinical trials, and 30 drugs onto the market. Through collaborations ... The drug is undergoing final IND-directed toxicology testing.. *SR13668, a novel inhibitor of the PI3K/Akt pathway. It is an ...
  https://www.sri.com/newsroom/press-releases/promising-cancer-therapeutics-developed-sri-international
*  Federal Register :: Agency Information Collection Activities; Submission for Office of Management and Budget...
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office ... Investigational New Drug Applications. A Notice by the Food and Drug Administration on 03/03/2015. ... by which FDA can monitor the clinical investigation of the safety and effectiveness of unapproved new drugs and biological ... Form FDA-1571-"Investigational New Drug Application." A person who intends to conduct a clinical investigation submits this ...
  https://www.federalregister.gov/documents/2015/03/03/2015-04379/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
*  Zavos Organization
... clinical research on investigational drugs and biological products can proceed only when an investigational new drug ... application (IND) is in effect. To date, FDA has not received an IND for the cloning of a human being. It should be noted that ... drug' under Section 2019(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act). Pursuant to regulations promulgated under ... The basis for FDA's jurisdiction derives from its classification of the somatic cell clone as a 'biological product' under ...
  http://zavos.org/library/articles/clone-in2001.htm
*  Newcastle Disease Virus (PDQ®): Integrative, alternative, and complementary therapies - Health Professional Information [NCI] |...
... application with the U.S. Food and Drug Administration (FDA). Biological materials and drugs have been held to similar safety ... researchers must file an Investigational New Drug (IND) ... In an IND application, researchers must provide safety and ... Curr Cancer Drug Targets 7 (2): 157-67, 2007.. * Karcher J, Dyckhoff G, Beckhove P, et al.: Antitumor vaccination in patients ... At present, at least one group of U.S. investigators has filed an IND application to study NDV as an anticancer treatment.[59] ...
  https://www.peacehealth.org/medical-topics/content/nci/ncicdr0000062978.html
*  Assays Archives - Page 3 of 5 - BioProcess InternationalBioProcess International | Page 3
... biological license application (BLA), and new drug application (NDA) submissions. Those activities often require elaborate ... but only biopharmaceuticals require functional potency assays for investigational new drug (IND), ... can be present in significant amounts in biological products through copurification with a recombinant protein-drug substance. ... Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in ...
  http://www.bioprocessintl.com/category/upstream-processing/assays/page/3/
*  US7275070B2 - System and method for managing the development and manufacturing of a pharmaceutical drug - Google...
The method comprises capturing and recording the development and manufacturing history of the pharmaceutical drug in order to ... components of the regulation module 200 are centered around the submission process of investigational and new drug applications ... By linking the chemical or biological structure to the process steps in the aforementioned manner, the system 5 is able to more ... The application programmer can register objects types in the application that would go through a workflow. The application can ...
  https://patents.google.com/patent/US7275070B2/en
*  DISSERTATIONS.SE: Kinetic Models in Life Science - Contributions to Methods and Applications
Dissertation: Kinetic Models in Life Science - Contributions to Methods and Applications. ... First, a model of the antiplatelet drug ticagrelor and the investigational antidote MEDI2452 was developed for the mouse. The ... and drug development. The idea of kinetic models is to represent a biological system by a number of biochemical reactions ... A validated model is used for simulation and analysis, which is interpreted to gain biological insights.. Three kinetic models ...
  http://www.dissertations.se/dissertation/81d8714101/
*  Nanotechnology Now - Press Release: PDS Biotechnology Corporation Progresses Development of Nanotechnology Cancer Therapies
HPV prior to filing of the Investigational New Drug Application. The NCL will perform selected physical, chemical and ... biological studies on behalf of the company at its facilities at the National Cancer Institute (NCI) in Frederick, Maryland. Dr ... Laboratory Management Web Application Goes Nationwide January 9th, 2018. NRL improves optical efficiency in nanophotonic ... The NCL is a formal collaboration between the US National Cancer Institute, the US Food and Drug Administration (FDA) and the ...
  http://www.nanotech-now.com/news.cgi?story_id=31282
*  Keystone Nano - Wikipedia
In January 2017, the FDA approved the investigational new drug application, NanoLiposome, to assess the product as a form of ... This process improves the delivery of both compounds by targeting tumors and extending the time of biological activity. ... "FDA Approves Investigational New Drug Application for Ceramide NanoLiposome". Pharmacy Times. Retrieved 14 January 2017. " ... "Investigational cancer compound receives FDA approval to begin human trials". Penn State News. ...
  https://en.wikipedia.org/wiki/Keystone_Nano
*  NIH Guide: NATIONAL GENE VECTOR LABORATORIES
Investigational New Drug (IND) applications are filed concerning clinical use of such products. Investigators planning clinical ... These may include: "Points to Consider in the Production and Testing of New Drugs and Biological Produced by Recombinant DNA ... Applications must adhere to the page limitations and Special Application Requirements noted under the section APPLICATION ... Applications received after this date will be returned. The Division of Research Grants (DRG) will not accept any application ...
  https://grants.nih.gov/grants/guide/rfa-files/RFA-RR-95-002.html
*  Trigen opens IND for the initiation of a Phase III programme for flovagatran (formerly TGN 255), its novel intravenous direct...
... today announced that following completion of appropriate regulatory procedures at the United States Federal Drug Administration ... An Investigational New Drug (IND) Application is a request made to the United States Food and Drug Administration (FDA) for ... drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application ... regulatory procedures at the United States Federal Drug Administration (FDA), the Investigational New Drug (IND) application ...
  http://www.marketwired.com/press-release/trigen-opens-ind-initiation-phase-iii-programme-flovagatran-formerly-tgn-255-its-novel-lse-tri-719420.htm
*  Tonix Pharmaceuticals to Present at the Dawson James Securities 3rd Annual Small Cap Growth Conference | Markets Insider
Investigational New Drug) application stage, designed as a daytime treatment for PTSD and TNX-801, a live synthetic version of ... Tonix is developing innovative pharmaceutical and biological products to address major public health challenges. In addition to ... In a recent Cross-Disciplinary Breakthrough Therapy meeting, the FDA confirmed that (i) a single-study new drug application ( ... TNX-102 SL is an investigational new drug and has not been approved for any indication. ...
  http://markets.businessinsider.com/news/stocks/tonix-pharmaceuticals-to-present-at-the-dawson-james-securities-3rd-annual-small-cap-growth-conference-1003969347
*  Tonix Pharmaceuticals Receives European Patent for the Active Ingredient in Tonmya® (Cyclobenzaprine HCl Sublingual Tablets...
Investigational New Drug) application stage, designed as a daytime treatment for PTSD and TNX-801, a live synthetic version of ... Tonix is developing innovative pharmaceutical and biological products to address major public health challenges. In addition to ... TNX-102 SL is an investigational new drug and has not been approved for any indication. ... Tonmya has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed trade name for TNX-102 SL ...
  http://markets.businessinsider.com/news/stocks/tonix-pharmaceuticals-receives-european-patent-for-the-active-ingredient-in-tonmya-cyclobenzaprine-hcl-sublingual-tablets-patent-will-provide-intellectual-property-protection-until-2030-for-use-1002372153
*  Becker Medical Library Scholarly Communications - The Blog for the WUSM Scholarly Communications Initiative
Investigational New Drug (IND) Applications. Inventions. Biological Materials. Pharmaceuticals. Medical Devices. Grant Awards: ... The United States Patent and Trademark Office provides patent application information. Search alerts for individual ...
  http://beckerinfo.net/scp/page/4/
*  Apexian Pharmaceuticals is Closing a Series A Round to Initiate Phase 1 Trial - News Press Release | PharmiWeb.com
The Investigational New Drug application was issued based on robust non-clinical data and a safety database of over 422 ... APX3330, the lead molecule for Apexian, has a unique dual biological role targeting the APE1/Ref-1 protein. The APE1 protein is ... Apexian's lead drug candidate APX3330, is an oral first-in-class novel inhibitor of the APE1 protein, a critical node in cancer ...
  https://www.pharmiweb.com/PressReleases/pressrel.asp?row_id=254220
*  The cruel sham that will not die: Right-to-try marches on in California and beyond - Science-Based Medicine
... biological product, or device, or the costs of services related to the use of an investigational drug, biological product, or ... evaluating nearly all new drug applications within 6 to 10 months, an impressive turnaround for such complex assessments. ... biological product, or device may make available the manufacturer's investigational drug, biological product, or device to an ... Let's take a look at the bill, AB-1668 Investigational drugs, biological products, and devices. Reading it over, I see that ...
  https://sciencebasedmedicine.org/the-cruel-sham-that-will-not-die-right-to-try-marches-on-in-california-and-beyond/
*  Federal Register :: Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious...
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain ... the sponsors of clinical studies of investigational xenotransplantation products under investigational new drug applications ( ... Although it is possible that a xenotransplantation product may not be regulated as a biological product (e.g., it may be ... "Investigational New Drug Application," 21 CFR 312.1 through 312.160, approved under OMB control number 0910-0014; and (3) ...
  https://www.federalregister.gov/documents/2009/07/10/E9-16334/agency-information-collection-activities-proposed-collection-comment-request-infectious-disease
*  Texas Applied Biomedical Services
The letter notes that because Celltex does not have an approved biologics license application (BLA) or Investigational New Drug ... application (IND) for the mesenchymal stem cells it manufactures the company is unlawfully marketing a biological drug. The ... had not submitted an Investigational New Drug application to the FDA, and was administering to study participants an unapproved ... biological drug.. It is possible that TABS' violations of federal regulations and Celltex's violations of federal regulations ...
  http://www.healthintheglobalvillage.com/tag/texas-applied-biomedical-services/
*  Rnl Bio | Health in the Global Village - Part 2
The letter notes that because Celltex does not have an approved biologics license application (BLA) or Investigational New Drug ... application (IND) for the mesenchymal stem cells it manufactures the company is unlawfully marketing a biological drug. The ... had not submitted an Investigational New Drug application to the FDA, and was administering to study participants an unapproved ... biological drug.. It is possible that TABS' violations of federal regulations and Celltex's violations of federal regulations ...
  http://www.healthintheglobalvillage.com/category/rnl-bio/page/2/
*  FDA Grants Priority Review for Genzyme's Cerdelga (eliglustat), an Investigational Oral Therapy for Gaucher Disease
... is a new drug in development for the treatment of Gaucher Disease. Cerdelga information includes news, clinical trial results ... regarding whether and when to approve any drug, device or biological application that may be filed for any such product ... Home › News › New Drug Applications › FDA Grants Priority Review for Genzyme's Cerdelga (eliglustat), an Investigational Oral ... Eliglustat, an investigational new drug, is a novel ceramide analog given orally and was designed to partially inhibit the ...
  https://www.drugs.com/nda/cerdelga_131211.html
*  5 Development of Cannabinoid Drugs | Marijuana and Medicine: Assessing the Science Base | The National Academies Press
Read chapter 5 Development of Cannabinoid Drugs: The medical use of marijuana is surrounded by a cloud of social, political, ... the manufacturer submits an Investigational New Drug (IND) application to the FDA. The IND submission contains a plan for human ... Guidance for industry: Providing clinical evidence of effectiveness for human drugs and biological products. Center for Drug ... supplemental application," or a "supplemental new drug application.'' Those terms connote that the application is supplemental ...
  https://www.nap.edu/read/6376/chapter/7
*  Investigator's brochure - Wikipedia
Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application [2] Code of Federal Regulations, Title 21 ... Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products - Content and Format. [4] CDER ... "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process ... Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format. [5] CDER ...
  https://en.wikipedia.org/wiki/Investigator's_brochure