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OPDP Part 99 Applications

Please be aware that Section 401 of the FDA Modernization Act of 1997, 21 U.S.C. § 360aaa, et seq., ceased to be effective on September 30, 2006. As a result, we are no longer evaluating whether information to be disseminated about unapproved/ new uses is consistent with the provisions of 21 CFR Part 99.

Page Last Updated: 12/15/2014
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