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2020 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter V - Drugs and Devices
Part E - General Provisions Relating to Drugs and Devices
United States Code, 2018 Edition, Supplement 2, Title 21 - FOOD AND DRUGS |
Bills and Statutes |
United States Code |
Y 1.2/5: |
Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part E - General Provisions Relating to Drugs and Devices |
sections 360bbb to 360bbb-8d |
2020 |
January 13, 2021 |
No |
standard |
- Sec. 360bbb - Expanded access to unapproved therapies and diagnostics
- Sec. 360bbb-0 - Expanded access policy required for investigational drugs
- Sec. 360bbb-0a - Investigational drugs for use by eligible patients
- Sec. 360bbb-1 - Dispute resolution
- Sec. 360bbb-2 - Classification of products
- Sec. 360bbb-3 - Authorization for medical products for use in emergencies
- Sec. 360bbb-3a - Emergency use of medical products
- Sec. 360bbb-3b - Products held for emergency use
- Sec. 360bbb-3c - Expedited development and review of medical products for emergency uses
- Sec. 360bbb-4 - Countermeasure development, review, and technical assistance
- Sec. 360bbb-4a - Priority review to encourage treatments for agents that present national security threats
- Sec. 360bbb-4b - Medical countermeasure master files
- Sec. 360bbb-5 - Critical Path Public-Private Partnerships
- Sec. 360bbb-6 - Risk communication
- Sec. 360bbb-7 - Notification
- Sec. 360bbb-8 - Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
- Sec. 360bbb-8a - Optimizing global clinical trials
- Sec. 360bbb-8b - Use of clinical investigation data from outside the United States
- Sec. 360bbb-8c - Patient participation in medical product discussion
- Sec. 360bbb-8d - Notification, nondistribution, and recall of controlled substances
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