Federal (United States) · Regulations
Subpart E — Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
7 sections
7 sections
- 21 C.F.R. § 601.40Scope.
- 21 C.F.R. § 601.41Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
- 21 C.F.R. § 601.42Approval with restrictions to assure safe use.
- 21 C.F.R. § 601.43Withdrawal procedures.
- 21 C.F.R. § 601.44Postmarketing safety reporting.
- 21 C.F.R. § 601.45Promotional materials.
- 21 C.F.R. § 601.46Termination of requirements.