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

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Applications for FDA Approval to Market a New Drug
  7. Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses

Checkout our iOS App for a better way to browser and research.

Section
314.500

Scope.

Section
314.510

Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

Section
314.520

Approval with restrictions to assure safe use.

Section
314.530

Withdrawal procedures.

Section
314.540

Postmarketing safety reporting.

Section
314.550

Promotional materials.

Section
314.560

Termination of requirements.