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Read Health Economics and Policy (James W. Henderson ) PDF FreeFast track is a designation by the United States Food and Drug Administration FDA of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. Fast Track is one of five Food and Drug Administration FDA approaches to make new drugs available as rapidly as possible:  the others are priority review , breakthrough therapy , accelerated approval and Regenerative Medicine Advanced Therapy. Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need.
Health Economics and Policy, 7th Edition_ James W. Henderson
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