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