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Book

Guidance for industry : variations in drug products that may be included in a single ANDA.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 1998 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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Drug approval

Book

Guidance for industry : changes to an approved NDA or ANDA.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 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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Drug approval

Book

Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 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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Drug approval

Book

Guidance for industry : major, minor, and telephone amendments to abbreviated new drug applications.
Author: Center for Drug Evaluation and Research (U.S.).
Year: 2001 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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Drug approval

Book

Guidance for industry : major, minor, and telephone amendments to abbreviated new drug applications.
Author: Center for Drug Evaluation and Research (U.S.).
Year: 2001 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
Drug approval

Book

Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 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
Drug approval

Book

Guidance for industry : variations in drug products that may be included in a single ANDA.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 1998 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
Drug approval

Book

Guidance for industry : changes to an approved NDA or ANDA.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 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
Drug approval

Book

Guidance for industry : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act.
Authors: Center for Drug Evaluation and Research (U.S.) --- Center for Biologics Evaluation and Research (U.S.)
Year: 1999 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,

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Pediatrics --- Drug approval

Book

Guidance for industry for the submission documentation for sterilization process validation in applications for human and veterinary drug products
Authors: Center for Drug Evaluation and Research (U.S.) --- Center for Veterinary Medicine (U.S.)
Year: 1994 Publisher: [Rockville, MD] : Center for Drug Evaluation and Research : Center for Veterinary Medicine,

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Drugs --- Drug approval --- Sterilization

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