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FDA Special Protocol Assessment
Results: 85

#	Item
71	Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Pharmaceutical sciences Pharmaceutical industry Drug safety Pharmacology Prescription Drug User Fee Act FDA Special Protocol Assessment Center for Biologics Evaluation and Research New Drug Application Food and Drug Administration Medicine Health
72	Survey of the Presentation of Sex Analysis in the FDA Review of Efficacy and Safety Clinical Data of New Molecular Entity Drugs and Biologics Approved From 2007 to 2009 Onyeka Otugo1, Rita Poon1, Vanessa Copeland1, Kesha Add to Reading List Source URL: www.fda.gov Language: English Research Food and Drug Administration Pharmacology New Drug Application Milnacipran Clinical trial Approved drug FDA Special Protocol Assessment Prescription Drug User Fee Act Pharmaceutical sciences Clinical research Pharmaceutical industry
73	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
74	Microsoft Word - 9124dft.doc Add to Reading List Source URL: www.fda.gov Language: English Design of experiments Clinical research Pharmaceutical industry Pharmacology Clinical trial Interim analysis Clinical study design Drug development FDA Special Protocol Assessment Medical statistics Science Research
75	CDER New Drug Review: 2011 Update Add to Reading List Source URL: www.fda.gov Language: English Medicinal chemistry Clinical pharmacology Pharmaceuticals policy Prescription Drug User Fee Act Pharmaceutical industry Center for Drug Evaluation and Research Drug discovery FDA Special Protocol Assessment Pharmaceutical sciences Food and Drug Administration Pharmacology
76	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
77	SAN DIEGO, October 25 /PRNewswire/ -- Essentialis, Inc Add to Reading List Source URL: www.forwardventures.com Language: English - Date: 2011-08-15 11:58:29 Clinical research Design of experiments Epidemiology Food and Drug Administration FDA Special Protocol Assessment Clinical trial Pharmaceutical sciences Pharmacology Research
78	PDUFA V Workload Adjuster Final Report Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Prescription Drug User Fee Act FDA Special Protocol Assessment Workload Investigational New Drug Federal Food Drug and Cosmetic Act New Drug Application Claims adjuster Center for Drug Evaluation and Research Food and Drug Administration Medicine Health
79	tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 77, No[removed]Wednesday, August 1, [removed]Notices Name of Committee: Blood Products Advisory Committee. General Function of the Committee: Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2012-08-01 03:23:01 Health Pharmaceutical sciences Food law Prescription Drug User Fee Act Pharmacology FDA Special Protocol Assessment Federal Food Drug and Cosmetic Act New Drug Application Center for Biologics Evaluation and Research Food and Drug Administration Medicine Pharmaceuticals policy
80	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

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