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Center for Drug Evaluation and Research
Results: 4314

#	Item
781	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
782	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2008-09-10 08:42:17 Food and Drug Administration Vaccines Food law Center for Biologics Evaluation and Research Influenza vaccine FluMist Federal Food Drug and Cosmetic Act Influenza Medicine Health Vaccination
783	Teleconference Summary - Provenge, February 1, 2007 Add to Reading List Source URL: www.fda.gov Language: English Dendreon Pharmaceutical industry Validation Food and Drug Administration Center for Biologics Evaluation and Research Pharmaceutical sciences Medicine Research
784	DEPARTMENT OF HEALTH AND HUMAN SERVICES ______________________________________________________________________________ TELECONFERENCE MEMORANDUM Date\Time: Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Dendreon Center for Biologics Evaluation and Research Biometrics Medicine Food and Drug Administration Clinical research
785	Guidance for Industry Providing Regulatory Submissions in Electronic Format — Add to Reading List Source URL: www.fda.gov. Language: English Health ISO standards Pharmaceutical industry Pharmaceuticals policy Title 21 CFR Part 11 United States administrative law Portable Document Format Center for Biologics Evaluation and Research Arial Food and Drug Administration Medicine Pharmaceutical sciences
786	Food and Drug Administration Center for Biologics Evaluation and Research 134th meeting of the Vaccines and Related Biological Products Advisory Committee via Teleconference Add to Reading List Source URL: www.fda.gov Language: English Medicine Food and Drug Administration Clinical pharmacology Therapeutics United States Public Health Service Center for Biologics Evaluation and Research Biologic Pharmacology Clinical research Pharmaceutical sciences
787	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 Health Pharmaceutical industry Clinical research Food and Drug Administration Generic drug Abbreviated New Drug Application Center for Drug Evaluation and Research Drug Price Competition and Patent Term Restoration Act Kefauver Harris Amendment Pharmaceutical sciences Pharmaceuticals policy Pharmacology
788	Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology March 14, 2012 Location: Gaylord National Resort & Conve Add to Reading List Source URL: www.fda.gov Language: English Physiologically based pharmacokinetic modelling Pharmacokinetics Food and Drug Administration Drug development Clinical trial Pharmaceutical sciences Pharmacology Clinical research
789	FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Nonprescription Drugs Advisory Committee (NDAC) Meeting Hilton Washington DC North/Gaithersburg, The Ballrooms 620 Perry Parkway, Gaithers Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Drugs Food and Drug Administration United States Public Health Service Montelukast Center for Drug Evaluation and Research Over-the-counter drug Prescription medication Pharmacology Pharmaceutical sciences Medicine
790	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. This content has not been altered or updated since it was archived Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical pharmacology Pharmacokinetics Drug development Bioavailability Center for Drug Evaluation and Research Adverse effect Food and Drug Administration Drug discovery Pharmaceutical sciences Pharmacology Medicinal chemistry

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