Subpart E - ACCELERATED APPROVAL OF BIOLOGICAL PRODUCTS FOR SERIOUS OR LIFE-THREATENING ILLNESSES
- Section 601.40 - Scope
- Section 601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity
- Section 601.42 - Approval with restrictions to assure safe use
- Section 601.43 - Withdrawal procedures
- Section 601.44 - Postmarketing safety reporting
- Section 601.45 - Promotional materials
- Section 601.46 - Termination of requirements