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 III
Effective Date: 03/04/2003
1. DIVISION OF CHEMISTRY III (DBNSBE).
A. Provides overall coordination for the review processes and initial administrative review of Abbreviated New Drug Applications (ANDAs).
B. Examines amendments, supplements, and reports to assure that submissions are complete and meets regulatory requirements.
C. Reviews and approves all aspects of labeling submissions for ANDAs, coordinating and consulting with the new drug divisions when necessary.
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.