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FDA Fast Track Development Program
Results: 173

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71	RESTRICTED I MARKETING UNDER ACCELERATED Add to Reading List Source URL: www.fda.gov Language: English - Date: 2000-06-26 03:45:46 Health Pharmacology Clinical research Drug safety Pharmacy New Drug Application Pharmaceutical industry FDA Fast Track Development Program Surrogate endpoint Food and Drug Administration Pharmaceutical sciences Medicine
72	FDA and Rare Diseases Anne Pariser, M.D. Office of New Drugs Center for Drug Evaluation and Research FDA Add to Reading List Source URL: www.pcori.org Language: English - Date: 2014-09-10 09:50:26 Pharmaceutical sciences Pharmacology Pharmaceuticals policy Drug discovery Pharmaceutical industry Prescription Drug User Fee Act FDA Fast Track Development Program Orphan drug Expanded access Food and Drug Administration Health Medicine
73	Support Accelerated Approval of Drugs for Ultra-Rare Diseases to Benefit Vulnerable Patients, Promote Biotechnology Innovation and Stimulate Job Growth in the United States January 4, 2012 The Honorable Fred Upton, Chair Add to Reading List Source URL: www.curesarcoma.org Language: English - Date: 2012-01-06 16:36:41 Neurodegenerative disorders Drug discovery Epidemiology Orphan drug Orphan Drug Act Niemann–Pick disease Batten disease FDA Fast Track Development Program Medical research Health Rare diseases Lipid storage disorders
74	Testimony Submitted by: Emil D. Kakkis, M.D. Ph.D. President & Founder of the Kakkis EveryLife Foundation 77 Digital Drive, Ste 210, Novato, CA[removed]Email: [removed] Phone: [removed] Add to Reading List Source URL: www.appropriations.senate.gov Language: English - Date: 2014-03-11 09:30:23 Pharmacology Food and Drug Administration Drug discovery Epidemiology Nursing research Orphan drug FDA Fast Track Development Program Orphan Drug Act Rare disease Medicine Health Pharmaceutical sciences
75	SFA PUBLIC STATEMENT JUNE[removed]Good morning, my name is Matthew Alsante, Executive Director of the Sarcoma Foundation of America. We are dedicated to reform of the status quo approaches towards rare solid tumors at Add to Reading List Source URL: www.curesarcoma.org Language: English - Date: 2011-02-11 10:54:19 Clinical pharmacology Pharmacology Therapeutics United States Public Health Service Hepatocellular carcinoma Cancer vaccine FDA Fast Track Development Program Criticism of the Food and Drug Administration Bevacizumab Medicine Health Food and Drug Administration
76	COMMITTEE ON SMALL BUSINESS CHAIRWOMAN COMMITTEE ON FINANCIAL Add to Reading List Source URL: www.curesarcoma.org Language: English - Date: 2009-06-07 11:59:43 Food and Drug Administration Medicinal chemistry Clinical pharmacology Therapeutics United States Public Health Service Andrew von Eschenbach Biologic FDA Fast Track Development Program Pharmacology Pharmaceutical sciences Clinical research
77	I 112TH CONGRESS 1ST SESSION H. R. 3737 Add to Reading List Source URL: www.curesarcoma.org Language: English - Date: 2012-01-06 16:39:36 Food and Drug Administration Medical statistics Research Drug discovery Medical terms FDA Fast Track Development Program Surrogate endpoint Orphan drug Clinical trial Epidemiology Health Medicine
78	h e a lt h p o l ic y b r i e f 1 w w w. h e a lt h a f fa i r s .o r g Add to Reading List Source URL: healthaffairs.org Language: English - Date: 2014-05-15 11:50:32 Pharmaceutical industry Health Clinical research Drug discovery FDA Fast Track Development Program New Drug Application Prescription Drug User Fee Act Clinical trial Didanosine Pharmaceutical sciences Food and Drug Administration Pharmacology
79	Microsoft Word - SFA Comments on FDA Guidance on Rare Disease Drug Development Add to Reading List Source URL: www.curesarcoma.org Language: English - Date: 2011-02-11 10:50:28 Medical statistics Clinical trials Epidemiology Pharmacology Clinical research End point of clinical trials Clinical endpoint Surrogate endpoint FDA Fast Track Development Program Medicine Health Research
80	Date: June 26, 2007 From: To: Lori Tull, Regulatory Management Staff, OCTGT, HFM – 705 The file, Dendreon STN[removed] 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

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