General Provisions Relating to Drugs and Devices | Midpage

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United States Code

Part E

General Provisions Relating to Drugs and Devices

360bbbExpanded access to unapproved therapies and diagnostics 360bbb–0Expanded access policy required for investigational drugs 360bbb–0aInvestigational drugs for use by eligible patients 360bbb–1Dispute resolution 360bbb–2Classification of products 360bbb–3Authorization for medical products for use in emergencies 360bbb–3aEmergency use of medical products 360bbb–3bProducts held for emergency use 360bbb–3cExpedited development and review of medical products for emergency uses 360bbb–4Countermeasure development, review, and technical assistance 360bbb–4aPriority review to encourage treatments for agents that present national security threats 360bbb–4bMedical countermeasure master files 360bbb–5Critical Path Public-Private Partnerships 360bbb–5aEmerging technology program 360bbb–6Risk communication 360bbb–7Notification 360bbb–8Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments 360bbb–8aOptimizing global clinical trials 360bbb–8bUse of clinical investigation data from outside the United States 360bbb–8cPatient participation in medical product discussion 360bbb–8dNotification, nondistribution, and recall of controlled substances