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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Sep 17, 2025
All Titles
Title 21
Chapter I
Part 314
Subpart H - Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
§ 314.500 - Scope.
§ 314.510 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
§ 314.520 - Approval with restrictions to assure safe use.
§ 314.530 - Withdrawal procedures.
§ 314.540 - Postmarketing safety reporting.
§ 314.550 - Promotional materials.
§ 314.560 - Termination of requirements.
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