Subpart H - ACCELERATED APPROVAL OF NEW DRUGS FOR SERIOUS OR LIFE-THREATENING ILLNESSES
- Section 314.500 - Scope
- Section 314.510 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity
- Section 314.520 - Approval with restrictions to assure safe use
- Section 314.530 - Withdrawal procedures
- Section 314.540 - Postmarketing safety reporting
- Section 314.550 - Promotional materials
- Section 314.560 - Termination of requirements