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U.S. Department of Health and Human Services

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SMG 1264.30

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

OFFICE OF GENERIC DRUGS

Effective Date: 03/04/2003

[PDF Version]

1. OFFICE OF GENERIC DRUGS (DBNSB).

A. Oversees the development and implementation of standards for the safety and effectiveness of generic drugs.

B. Reviews and evaluates Abbreviated New Drug Applications (ANDAs) and their amendments or supplements and determines approvability.

C. Establishes bioequivalency specifications for drug products and develops guidelines for bioequivalency reviews, industry protocols, and studies.

D. Oversees all aspects of labeling submissions for ANDAs.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Director, Center for Drug Evaluation and Research, effective March 4, 2003.

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