Individuals & Families
Small Businesses
Nonprofits
Employers
Employee Benefits Brokers
PEOs
Credit Unions
Membership Groups
Legal Information
Sign In
/
U.S. Code
/
TITLE 21 - FOOD AND DRUGS
/
CHAPTER 9—FEDERAL FOOD, DRU...
/
SUBCHAPTER V—DRUGS AND DEVI...
/
Part E—General Provisions Relating to Drugs and...
Part E—General Provisions Relating to Drugs and Devices (§§ 360bbb – 360bbb–8d)
§ 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–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