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 II
Effective Date: 03/04/2003
1. DIVISION OF CHEMISTRY II (DBNSBC).
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.