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U.S. Department of Health and Human Services

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SMG 1264.39

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

[PDF Version]

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 APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial05/25/2011N/aCDER/OMSecretary of Health and Human Services