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 MICROBIOLOGY
Effective Date: 05/25/2011
1. DIVISION OF MICROBIOLOGY (DBNSBH).
A. Evaluates sterility assurance data in Abbreviated New Drug· Applications (ANDAs) and supplements to ANDAs for products that are to be sterile.
B. Recommends approval, disapproval, or recommends changes in how to assure sterility of products.
C. Identifies potential sterility or product use issues and provides guidance for resolving the matters.
D. Reviews and evaluates specialized drug delivery systems to assure sterility of generic drug products.
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|