FDA’s Framework for Reviewing Regulations
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Transcript of FDA’s Framework for Reviewing Regulations
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FDA’s Framework for Reviewing Regulations
Leslie KuxActing Assistant Commissioner for Policy
U.S. Food and Drug AdministrationMarch 10, 2011
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Backdrop
• 1980's– The Regulatory Flexibility Act – EO 12291
• 1990's– EO 12866– REGO– FDA Modernization Act
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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
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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
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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