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 LABELING AND PROGRAM SUPPORT
Effective Date: 03/04/2003
1. DIVISION OF LABELING AND PROGRAM SUPPORT (DBNSBD).
1. Provides overall coordination for the review processes and initial administrative review of Abbreviated New Drug Applications (ANDAs).
2. Examines amendments, supplements, and reports to assure that submissions are complete and meets regulatory requirements.
3. Reviews and approves all aspects of labeling submissions for ANDAs, coordinating and consulting with the new drug divisions when necessary.
4. Monitors New Drug Applications (NDA) labeling, including patent and exclusivity status, to advise generic drug applicants of correct model labeling and to prepare and update labeling guidances.
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.