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