Biologic

Results: 1831



#Item
851Pharmacology / Medicine / Research / Clinical research / Pharmaceutical industry / New Drug Application / Term of patent in the United States / Biologic / Investigational New Drug / Food and Drug Administration / Pharmaceutical sciences / Drug safety

Public Health Service Food and Drug Administration Rockville MD[removed]NJG 3 I xl04

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Source URL: www.fda.gov

Language: English - Date: 2004-09-17 10:36:20
852Medicine / Pharmaceutical industry / Pharmaceuticals policy / Clinical research / Abbreviated New Drug Application / Biologic / Regulatory requirement / Bioequivalence / Generic drug / Pharmaceutical sciences / Pharmacology / Food and Drug Administration

Novartis Group - FDA Public Mtg Docket 12Nov04-Filed.doc

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Source URL: www.fda.gov

Language: English - Date: 2004-11-23 12:17:55
853Health / Prescription Drug User Fee Act / New Drug Application / Center for Biologics Evaluation and Research / Biologic License Application / Biologic / Food and Drug Administration / Pharmaceutical sciences / Medicine

AdvaMed Advanr rfd Medlt ;I/ Technology Assoclatioq October 18,2004

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Source URL: www.fda.gov

Language: English - Date: 2004-11-05 15:30:47
854Pharmacology / Clinical pharmacology / Therapeutics / United States Public Health Service / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Paracetamol / Biologic / Abbreviated New Drug Application / Food and Drug Administration / Medicine / Pharmaceutical sciences

November 15,2002 Mark D. Kramer Director, Combination Products Program Office of the Ombudsman Food and Drug Administration

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Source URL: www.fda.gov

Language: English - Date: 2003-02-06 07:12:31
855Center for Biologics Evaluation and Research / Influenza / Health / Biologic / Center for Drug Evaluation and Research / Bureau of Indian Affairs / Regulatory requirement / Government / Food and Drug Administration / Pharmacology / Medicine

Federal Rel~ster[removed] --

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Source URL: www.bia.gov

Language: English - Date: 2014-10-01 19:51:18
856Clinical research / Research / Validity / Clinical pharmacology / Validation / Food and Drug Administration / Biologic / Personal digital assistant / Stability / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

‘PDA June 14, 1999 Suite[removed]Old Georgetown Road Bethesda, MD[removed]USA

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Source URL: www.fda.gov

Language: English - Date: 1999-09-20 08:30:47
857Pharmacology / Biotechnology / Molecular biology / Emerging technologies / Food and Drug Administration / Gene therapy / Clinical trial / Biologic / Adverse effect / Medicine / Biology / Health

Gene Therapy Patient Tracking System

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Source URL: www.fda.gov.

Language: English
858Clinical research / Pharmaceutical sciences / Center for Biologics Evaluation and Research / Influenza / Biologic / Pharmacology / Medicine / Food and Drug Administration

Staff Manual Guide[removed]

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Source URL: www.fda.gov

Language: English
859Clinical 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
860Gene delivery / Emerging technologies / Pharmacology / Gene therapy / Viral vector / Retrovirus / Virus latency / Genetic engineering / Biologic / Biology / Molecular biology / Biotechnology

Microsoft Word - 05D-0310-emc0003-03.doc

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Source URL: www.fda.gov

Language: English - Date: 2005-12-08 09:58:51
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