Federal (United States) · Regulations
Subpart H — Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
7 sections
7 sections
- 21 C.F.R. § 314.500Scope.
- 21 C.F.R. § 314.510Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
- 21 C.F.R. § 314.520Approval with restrictions to assure safe use.
- 21 C.F.R. § 314.530Withdrawal procedures.
- 21 C.F.R. § 314.540Postmarketing safety reporting.
- 21 C.F.R. § 314.550Promotional materials.
- 21 C.F.R. § 314.560Termination of requirements.