Title 21Part

Part E—General Provisions Relating to Drugs and Devices

Contents

  1. § 360bbb. Expanded access to unapproved therapies and diagnostics
  2. § 360bbb–0. Expanded access policy required for investigational drugs
  3. § 360bbb–0a. Investigational drugs for use by eligible patients
  4. § 360bbb–1. Dispute resolution
  5. § 360bbb–2. Classification of products
  6. § 360bbb–3. Authorization for medical products for use in emergencies
  7. § 360bbb–3a. Emergency use of medical products
  8. § 360bbb–3b. Products held for emergency use
  9. § 360bbb–3c. Expedited development and review of medical products for emergency uses
  10. § 360bbb–4. Countermeasure development, review, and technical assistance
  11. § 360bbb–4a. Priority review to encourage treatments for agents that present national security threats
  12. § 360bbb–4b. Medical countermeasure master files
  13. § 360bbb–5. Critical Path Public-Private Partnerships
  14. § 360bbb–5a. Emerging technology program
  15. § 360bbb–6. Risk communication
  16. § 360bbb–7. Notification
  17. § 360bbb–8. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
  18. § 360bbb–8a. Optimizing global clinical trials
  19. § 360bbb–8b. Use of clinical investigation data from outside the United States
  20. § 360bbb–8c. Patient participation in medical product discussion
  21. § 360bbb–8d. Notification, nondistribution, and recall of controlled substances