21 CFR Subpart E
Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
June 25, 2020
§
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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