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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 27, 2025
All Titles
Title 21
Chapter I
Part 601
Subpart E - Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
§ 601.40 - Scope.
§ 601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
§ 601.42 - Approval with restrictions to assure safe use.
§ 601.43 - Withdrawal procedures.
§ 601.44 - Postmarketing safety reporting.
§ 601.45 - Promotional materials.
§ 601.46 - Termination of requirements.
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