Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 601
8. ›
9. Subpart E

Sections

• 601.40
  § 601.40 Scope.
• 601.41
  § 601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
• 601.42
  § 601.42 Approval with restrictions to assure safe use.
• 601.43
  § 601.43 Withdrawal procedures.
• 601.44
  § 601.44 Postmarketing safety reporting.
• 601.45
  § 601.45 Promotional materials.
• 601.46
  § 601.46 Termination of requirements.