Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses | Midpage

Collections
Code of Federal Regulations

Subpart H

Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses

314.500Scope.314.510Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.314.520Approval with restrictions to assure safe use.314.530Withdrawal procedures.314.540Postmarketing safety reporting.314.550Promotional materials.314.560Termination of requirements.