Accelerated Approval of Biological Products 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. Biologics
  6. Licensing
  7. Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses

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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.