Follow-up Review of the Food and Drug Administration's Generic Drug Management Information System

EXECUTIVE SUMMARY:

This final audit report presents the results of our follow-up review of the Food and Drug Administration's (FDA) progress in implementing recommendations contained in a prior report issued in July 1990. In that report we made recommendations on how the generic drug management information system could be better used by FDA to improve management and oversight of the generic drug review and approval process. Although the FDA has taken certain actions to implement the recommendations made in the previous report, more needs to be done. In the follow-up report we have made several recommendations to further improve the generic drug management information system.

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