SUBPART E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses (§601.40 to §601.46)
- 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.