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FDA Special Protocol Assessment
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41	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
42	Microsoft Word - Workload Adjustment Final Report for Changes in Review Activities-FINAL[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Prescription Drug User Fee Act FDA Special Protocol Assessment New Drug Application Investigational New Drug Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Federal Food Drug and Cosmetic Act Food and Drug Administration Pharmaceuticals policy Medicine
43	Guidance for Industry: Independent Consultants for Biotechnology Clinical Protocols Add to Reading List Source URL: www.fda.gov Language: English Clinical research Prescription Drug User Fee Act Center for Biologics Evaluation and Research FDA Special Protocol Assessment Center for Drug Evaluation and Research Dermatologic and Ophthalmic Drugs Advisory Committee Oncology Drug Advisory Committee Food and Drug Administration Medicine Health
44	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 It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Prescription Drug User Fee Act Orphan drug Center for Drug Evaluation and Research FDA Special Protocol Assessment Food and Drug Administration Pharmaceuticals policy Health
45	Meetings with FDA F DA Judit Milstein Chief Project Management Staff Division of Transplant and Ophthalmology Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceuticals policy Pharmaceutical industry Prescription Drug User Fee Act FDA Fast Track Development Program Drug development Biosimilar FDA Special Protocol Assessment New Drug Application Food and Drug Administration Pharmaceutical sciences Pharmacology
46	Meetings with FDA F DA Judit Milstein Chief Project Management Staff Division of Transplant and Ophthalmology Products Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceuticals policy Pharmaceutical industry Prescription Drug User Fee Act FDA Fast Track Development Program Biosimilar Drug development FDA Special Protocol Assessment Food and Drug Administration Pharmaceutical sciences Pharmacology
47	Important Aspects of FDA Safety and Innovation Act for Human Drugs and Biologics Patrick Frey Director, Office of Program and Strategic Analysis (OPSA) Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act FDA Special Protocol Assessment New Drug Application Center for Drug Evaluation and Research Investigational New Drug Center for Biologics Evaluation and Research Drug discovery Priority review voucher Food and Drug Administration Pharmaceutical sciences Medicine
48	Guidance for Industry Special Protocol Assessment U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Add to Reading List Source URL: www.fda.gov Language: English Clinical research FDA Special Protocol Assessment Prescription Drug User Fee Act Center for Biologics Evaluation and Research Clinical trial New Drug Application Center for Drug Evaluation and Research Communications protocol Regulatory requirement Food and Drug Administration Pharmaceutical sciences Health
49	FY 2000 PERFORMANCE REPORT TO CONGRESS for the Prescription Drug User Fee Add to Reading List Source URL: www.fda.gov Language: English Health Pharmacology Prescription Drug User Fee Act Pharmaceutical industry Food law Food and Drug Administration Modernization Act New Drug Application Drug development FDA Special Protocol Assessment Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
50	FY 2001 PERFORMANCE REPORT TO CONGRESS for the Prescription Drug User Fee Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act New Drug Application FDA Special Protocol Assessment Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences

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