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U.S Code last checked for updates: Nov 22, 2024
All Titles
Title 21
Chapter 9
Subchapter V
Part 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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