General Provisions Relating to Drugs and Devices

United States Code

U.S. Code most recently checked for updates: Jun 09, 2023

§ 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