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1 FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011.

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Presentation on theme: "1 FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011."— Presentation transcript:

1 1 FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011

2 2 Backdrop 1980's –The Regulatory Flexibility Act –EO 12291 1990's –EO 12866 –REGO –FDA Modernization Act

3 3 Formal Review Mechanisms: Final Rules Retrospective Review of Selected Regulations –Usually due to changed circumstances, e.g., out- dated, statutory revisions, harmonization Review When Revisions Made to Existing Rules –Is the specific regulation still valid, or should it be updated to reflect new policies, data, or technology

4 4 Formal Review Mechanisms: Final Rules Citizen Petition Process –21 CFR 10.30 610(c) Review Required by RFA –FDA uses Unified Agenda to notify public of upcoming reviews and solicit comment –Letters to Small Business Community

5 5 Formal Review Mechanisms: NPRMs and ANPRMs Periodic Review to Determine if Withdrawal Appropriate –Current policy is every 5 years (2008; 2003;1994;1991) –Publish Notice in FR of candidate rules all NPRMs and ANPRMs published more than 5 years ago

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