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SMG 1264.32

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

DIVISION OF CHEMISTRY I

Effective Date: 03/04/2003

[PDF Version]

1. DIVISION OF CHEMISTRY I (DBNSBB).

A. Evaluates and determines approvability of scientific data of original and amended Abbreviated New Drug Applications (ANDAs).

B. Evaluates and approves or disapproves supplements involving manufacturing and manufacturing controls.

C. Receives, processes, controls, and insures the security of Investigational New Drug (INDs) and ANDAs assigned to the division.

2. AUTHORITY AND EFFECTIVE DATE.

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