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U.S Code last checked for updates: May 14, 2025
All TitlesTitle 21Chapter 9Subchapter VPart E
  • § 360bbb. Expanded access to unapproved therapies and diagnostics
  • § 360bbb-0. Expanded access policy required for investigational drugs
  • § 360bbb-0a. Investigational drugs for use by eligible patients
  • § 360bbb-1. Dispute resolution
  • § 360bbb-2. Classification of products
  • § 360bbb-3. Authorization for medical products for use in emergencies
  • § 360bbb-3a. Emergency use of medical products
  • § 360bbb-3b. Products held for emergency use
  • § 360bbb-3c. Expedited development and review of medical products for emergency uses
  • § 360bbb-4. Countermeasure development, review, and technical assistance
  • § 360bbb-4a. Priority review to encourage treatments for agents that present national security threats
  • § 360bbb-4b. Medical countermeasure master files
  • § 360bbb-5. Critical Path Public-Private Partnerships
  • § 360bbb-5a. Emerging technology program
  • § 360bbb-6. Risk communication
  • § 360bbb-7. Notification
  • § 360bbb-8. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
  • § 360bbb-8a. Optimizing global clinical trials
  • § 360bbb-8b. Use of clinical investigation data from outside the United States
  • § 360bbb-8c. Patient participation in medical product discussion
  • § 360bbb-8d. Notification, nondistribution, and recall of controlled substances
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