21 CFR Part 314 - Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
- § 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.
Source:
57 FR 58958, Dec. 11, 1992, unless otherwise noted.