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