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FDAMA Plan For Statutory Compliance

Objective E Requirements:
Mechanisms for Meeting Review Time Periods (July 2, 1999)

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:

  1. the six strategic directions (as listed in the FDA Plan for Statutory Compliance);
  2. the primary process used to accomplish the activity; and
  3. the FDA organizational unit initiating it.

Contents of this report:

Summary Report on Mechanisms

List of Mechanisms

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