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FDA Office of Generic Drugs

Executive Summary

Sterility assurance reviews for ANDAs/AADAs will be handled by OGD staff, office says in Nov. 4 revision to Policy and Procedure Guide #4-89. Microbiology reviews have in the past been conducted by FDA's Medical Imaging, Surgical and Dental Drug Products Division. OGD "now has staff microbiologists to provide timely sterility assurance review of all ANDAs and AADAs," office says.
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