21 USC Part E
General Provisions Relating to Drugs and Devices
through Pub. L. 116-282, except Pub. L. 116-260
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360bbb
Expanded access to unapproved therapies and diagnostics
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360bbb-0
Expanded access policy required for investigational drugs
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360bbb-0a
Investigational drugs for use by eligible patients
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360bbb-1
Dispute resolution
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Classification of products
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Authorization for medical products for use in emergencies
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Emergency use of medical products
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Products held for emergency use
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Expedited development and review of medical products for emergency uses
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Countermeasure development, review, and technical assistance
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360bbb-4a
Priority review to encourage treatments for agents that present national security threats
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Medical countermeasure master files
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Critical Path Public-Private Partnerships
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Risk communication
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Notification
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Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
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Optimizing global clinical trials
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Use of clinical investigation data from outside the United States
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360bbb-8c
Patient participation in medical product discussion
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360bbb-8d
Notification, nondistribution, and recall of controlled substances