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2006 (50)

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Book
Guidance for industry : investigating out-of-specification test results (OOS) for pharmaceutical production.
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Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Keywords

Drug testing


Book
Guidance for industry : Prescription Drug Marketing Act (PDMA) requirements, questions and answers.
Authors: ---
Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Office of the Commissioner : Office of Regulatory Affairs,

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Keywords

United States.


Book
Guidance for industry : nonclinical safety evaluation of drug or biologic combinations.
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Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Keywords

Drugs --- Biologicals --- Testing.


Book
Guidance for industry : nonclinical safety evaluation of pediatric drug products.
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Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Keywords

Drugs --- Pediatrics --- Testing.


Book
Guidance for industry : Prescription Drug Marketing Act, donation of prescription drug samples to free clinics.
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Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Book
Guidance for industry : antiviral product development, conducting and submitting virology studies to the agency.
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Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Book
Guidance for industry : public availability of labeling changes in "changes being effected" supplements.
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Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Keywords

Drugs --- Biologicals --- Labeling


Book
From test tube to patient : protecting America's health through human drugs.
Authors: ---
Year: 2006 Publisher: [Rockville (Md.)] : U.S. Department of Health and Human Services, U.S. Food and Drug Administration,

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Book
Guidance for industry and review staff : recommended approaches to integration of genetic toxicology study results.
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Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Abstract


Book
Guidance for industry : nonclinical safety evaluation of drug or biologic combinations.
Author:
Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Abstract

Keywords

Drugs --- Biologicals --- Testing.

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