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In Brief: Office of Generic Drugs

Executive Summary

Office of Generic Drugs: Institutes random assignment policy for ANDAs, AADAs, and related documents, to bioequivalence reviewers under the office's "Policy and Procedure Guide #42-95" issued June 9. The policy is being implemented in response to recommendations made in a May 1992 HHS Inspector General report on FDA's generic drug approval process following the generic drug scandal. Random assignment of chemistry reviews was implemented in June 1992...
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PS026379

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