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The Food and Drug Administration Modernization Act of 1997 includes a requirement [Objective E] for establishing mechanisms, by July 1, 1999, for meeting the time periods specified in the Federal Food, Drug and Cosmetic Act for the review of all applications and submissions presented to the Agency.
A compilation of 110 mechanisms were identified which we are using, or planning to use, to meet FDA's review time requirements. The mechanisms have been categorized by three criteria: