Subpart E. Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses

• § 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.