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 IV
Effective Date: 05/25/2011
1. DIVISION OF CHEMISTRY IV (DBNSBI).
A. Evaluates chemistry, manufacturing and controls information in Abbreviated New Drug· Applications (ANDAs) and their supplements and amendments.
B. Recommends approval, disapproval, or additional development work.
C. Identifies potential issues related to the manufacturing processes utilized by ANDA sponsors.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of Health and Human Services effective, May 25, 2011.
|STATUS (I, R, C)||DATE APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||05/25/2011||N/a||CDER/OM||Secretary of Health and Human Services|