21 CFR 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.
Source:
57 FR 58959, Dec. 11, 1992, unless otherwise noted.