Subpart H. 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.