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FDA Fast Track Development Program
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31	U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Medical statistics Health Epidemiology Medical research Surrogate endpoint End point of clinical trials Progression-free survival Ovarian cancer FDA Fast Track Development Program Medicine Clinical trials Medical terms
32	Gastrointestinal Drugs Advisory Committee Meeting NSAID-Associated Gastric and/or Duodenal Ulcers as Endpoints to Support Product Labeling November 4, 2010 Add to Reading List Source URL: www.fda.gov Language: English Clinical research FDA Fast Track Development Program Surrogate endpoint Center for Drug Evaluation and Research Imaging biomarker Food and Drug Administration Medicine Health
33	Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs Cataloguing FDA’s Flexibility in Regulating Therapies for Persons with Rare Disorders by Frank J. Sasinowski, M.S., M.P.H., J.D.1 Chairman of the Bo Add to Reading List Source URL: rarediseases.org Language: English - Date: 2012-12-18 11:57:21 Medicine Pharmaceuticals policy Pharmacology Clinical research Pharmaceutical industry Orphan drug Xyrem Orphan Drug Act FDA Fast Track Development Program Health Food and Drug Administration Pharmaceutical sciences
34	Microsoft Word - Background Information.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical research Pharmaceutical industry Drug discovery Center for Drug Evaluation and Research FDA Fast Track Development Program Drug development Clinical trial Chronic fatigue syndrome Health Food and Drug Administration Pharmaceutical sciences
35	BLA Teleconference Summary - Provenge, June 26, 2007 Add to Reading List Source URL: www.fda.gov Language: English Clinical research FDA Special Protocol Assessment Center for Biologics Evaluation and Research Dendreon Cancer vaccine FDA Fast Track Development Program Food and Drug Administration Medicine Health
36	Quality Risk Management and Submission Strategies for Breakthrough Therapies IFPAC/Washington DC January 22, 2014 Sarah Pope Miksinski, Ph.D. Add to Reading List Source URL: www.fda.gov Language: English Health Pharmacology Clinical pharmacology Therapeutics United States Public Health Service FDA Fast Track Development Program Investigational New Drug Food and Drug Administration Pharmaceutical sciences Medicine
37	DECEMBER[removed]FY 2012 Innovative Drug Approvals Bringing Life-saving Drugs to Patients Quickly and Efficiently http://www.fda.gov/AboutFDA /ReportsManualsForms/Reports/ucm276385.htm Add to Reading List Source URL: www.fda.gov. Language: English Health Pharmaceuticals policy Pharmaceutical industry Drug discovery Prescription Drug User Fee Act FDA Fast Track Development Program Orphan drug Drug development Didanosine Pharmaceutical sciences Food and Drug Administration Pharmacology
38	Richard Moscicki - Priorities for CDER[removed] Add to Reading List Source URL: www.fda.gov. Language: English Clinical research Health Drug discovery Pharmaceutical industry Pharmaceuticals policy Prescription Drug User Fee Act FDA Fast Track Development Program Center for Drug Evaluation and Research Biologic Food and Drug Administration Pharmaceutical sciences Pharmacology
39	DOC Document Add to Reading List Source URL: www.eyeonfda.com Language: English - Date: 2010-10-27 15:33:23 Medicine Prescription Drug User Fee Act New Drug Application Off-label use Investigational New Drug Pharmaceutical industry Clinical research FDA Fast Track Development Program Boxed warning Food and Drug Administration Pharmaceutical sciences Health
40	APPROVED DRUGS[removed]Adempas Anoro Ellipta Add to Reading List Source URL: www.fda.gov. Language: English Clinical research Pharmaceutical industry Clinical pharmacology Center for Drug Evaluation and Research Prescription Drug User Fee Act Drug development FDA Fast Track Development Program New Drug Application Drug discovery Pharmaceutical sciences Food and Drug Administration Pharmacology

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