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FDA Special Protocol Assessment
Results: 85

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21	FY 2003 PERFORMANCE REPORT 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
22	FY 2003 PERFORMANCE REPORT Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Food law FDA Special Protocol Assessment Drug safety New Drug Application FY Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
23	Draft — Not for Implementation Attachment IV Sample Formats — User Fee Form FDA 3397 for Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Food law Pharmaceutical industry Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act New chemical entity New Drug Application FDA Special Protocol Assessment Food and Drug Administration Pharmaceutical sciences Pharmaceuticals policy
24	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
25	How to prepare for a successful meeting Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act FDA Special Protocol Assessment Center for Drug Evaluation and Research Meeting Food and Drug Administration Pharmaceutical sciences Clinical research
26	Statistical Review, May 16, [removed]Ruconest Add to Reading List Source URL: www.fda.gov Language: English Chemistry Complement deficiency Epidemiology Medicine Medical statistics Hereditary angioedema Randomized controlled trial FDA Special Protocol Assessment Clinical trial Health Clinical research Design of experiments
27	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
28	Guidance for Industry Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-10-01 17:09:43 Pharmaceutical sciences Prescription Drug User Fee Act FDA Special Protocol Assessment Center for Biologics Evaluation and Research Investigational New Drug New Drug Application Center for Drug Evaluation and Research Drug development Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
29	December 14, 2005 Reference No.: FDAA05019 Dockets Management Branch, HFA-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: 2006-01-05 12:40:50 Pharmaceutical sciences Prescription Drug User Fee Act FDA Special Protocol Assessment New Drug Application Center for Biologics Evaluation and Research Plasmapheresis Food and Drug Administration Medicine Health
30	Comments on Guidance for Industry and FDA Staff: Application User Fees for Combination Products Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-01-05 16:26:05 Pharmaceutical sciences Prescription Drug User Fee Act Premarket approval Center for Devices and Radiological Health Medtronic Center for Drug Evaluation and Research Abbreviated New Drug Application FDA Special Protocol Assessment New Drug Application Food and Drug Administration Medicine Health

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