User fee

Results: 1551



#Item
581Pharmacology / Health / Pharmaceuticals policy / Pharmaceutical industry / Drug safety / New Drug Application / Prescription Drug User Fee Act / Pharmacovigilance / Rosiglitazone / Pharmaceutical sciences / Food and Drug Administration / Medicine

1 DEPARTMENT OF HEALTH AND HUMAN SERVICESPRIVATE

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Source URL: www.fda.gov

Language: English - Date: 2002-09-18 17:34:53
582Pharmaceuticals policy / Technology / Food law / Prescription Drug User Fee Act / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Medical device / Abbreviated New Drug Application / New Drug Application / Food and Drug Administration / Medicine / Health

1200 G Street NW, Suite 400 Washington, DC 20005–3814 Tel: [removed]Fax: [removed]www.AdvaMed.org

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Source URL: www.fda.gov

Language: English - Date: 2005-01-05 16:26:05
583Clinical research / Pharmacology / Pharmaceuticals policy / Prescription Drug User Fee Act / Drug safety / New Drug Application / Biosimilar / Biologic / Email / Food and Drug Administration / Medicine / Pharmaceutical sciences

SOPP[removed]: Procedures for Resubmissions of an Application or Supplement Version # 4 Effective Date: October 1, 2012 I. Purpose This Standard Operating Policy and Procedure (SOPP) describes the policies and procedures f

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Source URL: www.fda.gov

Language: English
584Clinical research / Prescription Drug User Fee Act / Eschenbach / Food and Drug Administration / Steven K. Galson / Raymond L. Woosley / Health / Pharmaceutical sciences / Andrew von Eschenbach

1 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION PRESCRIPTION DRUG USER FEE ACT (PDUFA) FDA AND STAKEHOLDERS PUBLIC MEETING

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Source URL: www.fda.gov

Language: English - Date: 2005-12-29 12:36:02
585Pharmaceutical 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

December 14, 2005 Reference No.: FDAA05019 Dockets Management Branch, HFA-305 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

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Source URL: www.fda.gov

Language: English - Date: 2006-01-05 12:40:50
586Pharmacology / Pharmaceuticals policy / Therapeutics / United States Public Health Service / Biotechnology / Prescription Drug User Fee Act / Pharmaceutical sciences / Food and Drug Administration / Clinical research

BIOTECHNOLOGY .__l___-l__INDUSTRY ._.____---ORGANIZATION .-.....

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Source URL: www.fda.gov

Language: English - Date: 2004-11-12 10:50:34
587Health / Food and Drug Administration / Pharmaceuticals policy / Pharmacy / Pharmaceutical industry / Boxed warning / Adverse effect / Prescription Drug User Fee Act / Center for Drug Evaluation and Research / Pharmaceutical sciences / Pharmacology / Medicine

Statement of Sidney M. Wolfe, MD and Larry D. Sasich, Pharm.D., Public Citizen Health Research Group FDA Hearing on Risk Management of Prescription Drugs (docket number 02N-0115)

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Source URL: www.fda.gov

Language: English - Date: 2002-11-06 16:09:27
588Health / Medicine / Food law / Pharmacology / Prescription Drug User Fee Act / New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Pharmaceutical industry / Food and Drug Administration / Pharmaceuticals policy / Pharmaceutical sciences

Alan Goldhammer, PhD Associate Vice President, US Regulatory Affairs

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Source URL: www.fda.gov

Language: English - Date: 2004-11-05 15:26:13
589Food and Drug Administration / Health / Prescription Drug User Fee Act / Drug safety / Wyeth / Over-the-counter drug / Pharmaceuticals policy / Pharmacology / Pharmaceutical sciences

Wyeth Wyeth Pharmaceuticals

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Source URL: www.fda.gov

Language: English - Date: 2003-10-27 08:41:11
590Pharmacology / Drug safety / Health / Clinical research / Prescription Drug User Fee Act / Pharmaceutical industry / New Drug Application / Food and Drug Administration / Pharmaceutical sciences / Pharmaceuticals policy

Alan Goldhammer, PhD Associate Vice President, US Regulatory Affairs

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Source URL: www.fda.gov

Language: English - Date: 2003-10-27 08:41:10
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