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FDA Special Protocol Assessment
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31	ti!PPTAA Plasma Protein Therapeutics Association December 14,2005 Reference No.: FDAAO5019 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2006-01-03 18:15:54 Pharmaceutical sciences Prescription Drug User Fee Act FDA Special Protocol Assessment Plasmapheresis New Drug Application Center for Biologics Evaluation and Research Food and Drug Administration Medicine Health
32	Opportunities for Interactions with FDA: CDER and CDRH Perspectives Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Investigational Device Exemption Center for Devices and Radiological Health FDA Special Protocol Assessment Center for Drug Evaluation and Research Premarket approval Oritavancin Food and Drug Administration Pharmaceutical sciences Medicine
33	SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act Center for Biologics Evaluation and Research New Drug Application Patent application Biologic License Application FDA Special Protocol Assessment Food and Drug Administration Pharmaceuticals policy Medicine
34	FY 2011 Performance Report to the President and Congrress for the Prescription Drug User Fee Act (PDUFA) Add to Reading List Source URL: www.fda.gov Language: English Prescription Drug User Fee Act Pharmacology Health FDA Special Protocol Assessment New Drug Application Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
35	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
36	White Paper Prescription Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications Executive Summary The Prescription Drug User Fee Act (PDUFA) program is the cornerston Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceutical industry Prescription Drug User Fee Act Pharmacology Drug safety FDA Special Protocol Assessment New Drug Application Center for Drug Evaluation and Research Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
37	SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA) Version # 7 Effective Date: April 25, 2013 ___________________________________________________________ Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Food law Prescription Drug User Fee Act Drug safety Center for Biologics Evaluation and Research New Drug Application Federal Food Drug and Cosmetic Act FDA Special Protocol Assessment Food and Drug Administration Medicine Pharmaceuticals policy
38	CLINICAL REVIEW Division of Clinical Evaluation, Office of Cellular Tissue and Gene Therapy, Center for Biologics Evaluation and Research ________________________________________________________________________ TITLE AND Add to Reading List Source URL: www.fda.gov Language: English Biology Clinical trial FDA Special Protocol Assessment Food and Drug Administration Cell therapy Pharmacovigilance ArteFill Ustekinumab Pharmaceutical sciences Pharmacology Clinical research
39	[removed]Ella Clinical PREA Add to Reading List Source URL: www.fda.gov Language: English Endocrine system Medicine Emergency contraception Combined oral contraceptive pill Mifepristone FDA Special Protocol Assessment Selective progesterone receptor modulator Food and Drug Administration Hormonal contraception Ulipristal acetate Pharmacology
40	Stat NDA Template Draft 2 Add to Reading List Source URL: www.fda.gov Language: English Epidemiology Pharmacology Science Clinical trial Pharmaceutical industry FDA Special Protocol Assessment Scientific method ArteFill Clinical research Research Design of experiments

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