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Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter F
Part 601
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.