Part E. General Provisions Relating to Drugs and Devices
- § 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