- § 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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