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FDA Special Protocol Assessment
Results: 85

#	Item
11	FY 2013 BsUFA Financial Report Add to Reading List Source URL: www.fda.gov Language: English Biosimilar Biotechnology Drugs Food and Drug Administration Biologic FDA Special Protocol Assessment Pharmacology Clinical research Pharmaceutical sciences
12	Background Document for Meeting of Advisory Committee for Reproductive Health Drugs March 4, 2013 NDA[removed]Gabapentin tablets 600 mg Add to Reading List Source URL: www.fda.gov Language: English Brain Neurology Pfizer Gabapentin Menopause Off-label use FDA Special Protocol Assessment Estrogen New Drug Application Medicine Analgesics Anticonvulsants
13	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
14	PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017 Add to Reading List Source URL: www.fda.gov. Language: English Food and Drug Administration Pharmaceuticals policy Biosimilar Biotechnology Drugs Prescription Drug User Fee Act FDA Special Protocol Assessment Clinical trial Regulatory requirement Pharmaceutical sciences Pharmacology Clinical research
15	Prescription Drug User Fee Act (PDUFA) Webinar 1 Add to Reading List Source URL: www.fda.gov Language: English Medicine Prescription Drug User Fee Act Pharmaceutical sciences FDA Special Protocol Assessment Abbreviated New Drug Application Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Priority review voucher Food and Drug Administration Pharmaceuticals policy Health
16	Microsoft Word - PDUFA V Committment Letter[removed]docx Add to Reading List Source URL: www.fda.gov. Language: English Prescription Drug User Fee Act Health New Drug Application FDA Special Protocol Assessment Priority review voucher Food and Drug Administration Pharmaceutical sciences Pharmacology
17	Revisions to Guidance to Industry 2125fnl.PDF Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Prescription Drug User Fee Act Center for Biologics Evaluation and Research New Drug Application Investigational New Drug FDA Special Protocol Assessment Center for Drug Evaluation and Research Biologic Generic drug Food and Drug Administration Medicine Health
18	SOPP[removed]: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants Version #5 Effective Date: October 15, 2012 I. Purpose Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences FDA Special Protocol Assessment Prescription Drug User Fee Act New Drug Application FDA Fast Track Development Program Center for Biologics Evaluation and Research Meeting Investigational New Drug Validation Food and Drug Administration Medicine Health
19	FY 2003 PERFORMANCE REPORT Add to Reading List Source URL: www.fda.gov Language: English Prescription Drug User Fee Act Health Pharmacology Food law FDA Special Protocol Assessment Abbreviated New Drug Application Approved drug Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
20	Microsoft Word - Report to Congress - PDUFA Perf Report 041.doc Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act FDA Special Protocol Assessment New Drug Application Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences

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