SMG 1264.38

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

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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