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FDA Fast Track Development Program
Results: 173

#	Item
51	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: nordphysicianguides.org Language: English - Date: 2013-06-21 13:23:45 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
52	Prospects for Rapid Advances in the Development of New Medicines for Special Medical Needs Add to Reading List Source URL: www.nature.com Language: English - Date: 2014-02-03 14:11:10 Health Pharmacology Pharmaceuticals policy Drug safety Pharmaceutical industry Prescription Drug User Fee Act FDA Fast Track Development Program Expanded access Orphan drug Food and Drug Administration Pharmaceutical sciences Medicine
53	November 13,2003 Mark McClellan, M.D. Commissioner Food and Drug Administration 5600 Fishers Lane Room HF- 1 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-10 17:35:09 Medicine Health Pharmaceutical industry Drug discovery Clinical research Expanded access Clinical trial Drug development FDA Fast Track Development Program Pharmacology Pharmaceutical sciences Food and Drug Administration
54	January 30, 2013 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room[removed]HFA-305) Rockville, MD 20852 Add to Reading List Source URL: npalliance.org Language: English - Date: 2013-02-02 06:51:24 Health Clinical research Pharmaceutical industry Therapeutics Antipsychotic Off-label use Atypical antipsychotic Boxed warning FDA Fast Track Development Program Pharmacology Pharmaceutical sciences Food and Drug Administration
55	Microsoft Word - MY Letter to Cures 21st Century July 2014.docx Add to Reading List Source URL: energycommerce.house.gov Language: English - Date: 2014-07-29 12:45:15 Pharmaceutical sciences Pharmacology Clinical research Pharmaceutical industry Pharmaceuticals policy Lyme disease Infectious Diseases Society of America Duchenne muscular dystrophy FDA Fast Track Development Program Food and Drug Administration Health Medicine
56	February 16, 1999 BY MESSENGER Dockets Management Branch (HFD-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Add to Reading List Source URL: www.fda.gov Language: English - Date: 1999-10-19 05:16:16 Pharmacology Medicine Pharmaceuticals policy Clinical research Pharmaceutical industry FDA Fast Track Development Program Clinical trial Food and Drug Administration Health Pharmaceutical sciences
57	July 25, 2014 The Honorable Doris Matsui U.S. House of Representatives 2434 Rayburn Building Washington, D.C[removed]The Honorable Bill Johnson Add to Reading List Source URL: energycommerce.house.gov Language: English - Date: 2014-07-31 11:03:59 Health Medicine Pharmaceutical industry Clinical research Drug discovery Clinical trial FDA Fast Track Development Program Approved drug Medicare Pharmaceutical sciences Pharmacology Food and Drug Administration
58	. BY MESSENGER Janet Woodcock, MD Director, Center for Drug Evaluation and Research Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English - Date: 1998-05-29 15:54:26 Health FDA Fast Track Development Program PolyHeme Prescription Drug User Fee Act Food and Drug Administration Pharmaceutical sciences Medicine
59	DOC Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-10-06 09:58:54 Pharmaceutical sciences New Drug Application Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Regulatory requirement FDA Fast Track Development Program Prescription Drug User Fee Act Food and Drug Administration Health Medicine
60	)EPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 Add to Reading List Source URL: www.fda.gov Language: English - Date: 1999-10-13 09:50:22 Clinical research Pharmacology Food law Epidemiology Medical statistics Food and Drug Administration Modernization Act FDA Fast Track Development Program Surrogate endpoint Title 21 of the Code of Federal Regulations Food and Drug Administration Medicine Health

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