Code of Federal Regulations · Subpart

Subpart E — Accelerated Approval Of Biological Products For Serious Or Life-threatening Illnesses

21 C.F.R. pt. 601, subpt. E

• § 601.40 Scope
• § 601.41 Approval Based On A Surrogate Endpoint Or On An Effect On A Clinical Endpoint Other Than Survival Or Irreversible Morbidity
• § 601.42 Approval With Restrictions To Assure Safe Use
• § 601.43 Withdrawal Procedures
• § 601.44 Postmarketing Safety Reporting
• § 601.45 Promotional Materials
• § 601.46 Termination Of Requirements