Code of Federal Regulations · Subpart

Subpart H — Accelerated Approval Of New Drugs For Serious Or Life-threatening Illnesses

21 C.F.R. pt. 314, subpt. H

• § 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