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Last edited by ImportBot
September 11, 2008 | History
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Center for Drug Evaluation and Research (U.S.)

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  • Cover of: Guidance for industry: providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling

    First published in 1995 — 6 editions
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  • Cover of: Guidance for industry, q & a: content and format of INDs for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products

    First published in 2000 — 1 edition
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  • Cover of: S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use

    First published in 2008 — 1 edition
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  • Cover of: Guidance for industry: content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.

    First published in 1995 — 1 edition
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  • Cover of: Guidance for industry: content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products

    First published in 1995 — 1 edition
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  • Cover of: From test tube to patient: improving health through human drugs

    First published in 1999 — 1 edition
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  • Cover of: Guideline for the format and content of the clinical and statistical sections of an application

    First published in 1988 — 1 edition
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  • Cover of: Guideline for the study of drugs likely to be used in the elderly

    First published in 1990 — 1 edition
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  • Cover of: Guideline for Drug Master Files

    First published in 1989 — 1 edition
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  • Cover of: FDA, Center for Drug Evaluation and Research: report to industry 1996.

    First published in 1997 — 1 edition
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  • Cover of: Guideline on validation of the Limulus Amebocyte Lysate test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices

    First published in 1987 — 1 edition
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  • Cover of: Guideline for industry: for the submission of an environmental assessment in human drug applications and supplements.

    First published in 1995 — 1 edition
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  • Cover of: Drugs@FDA

    First published in 2004 — 1 edition
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  • Cover of: National drug code directory

    First published in 2001 — 1 edition
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Subjects

Drugs, Pharmaceutical policy, Research, Testing, Handbooks, manuals, Center for Drug Evaluation and Research (U.S.), Government policy, Analysis, Biotechnology, Code numbers, Databases, Drug approval, Drug use, Endotoxins, Evaluation, Experimental Medicine, Genetic toxicology, Indexes, Information services, Information storage and retrieval systems, Law and legislation, Limulus test, Nonprescription Drugs, Older people, Pharmacy

Places

United States

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ID Numbers

  • OLID: OL4549555A

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History

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September 11, 2008 Created by ImportBot Imported from Western Washington University MARC record