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Fast 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 that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company.
The fast track programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that ...
Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit, such as increased survival for cancer patients. Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate endpoint, or something that is thought to predict clinical benefit.
By definition, it implies that a less direct, slower route also exists. Fast track or Fast Track may also refer to: FDA Fast Track Development Program, FDA granted Fast Track Designation for investigational drugs; Fast Track, a FoxBusiness.com show hosted by Anna Gilligan; Fast Track (UK TV series), a travel programme
The FDA's "Fast Track" designation is intended to facilitate the development and expedite the review of potentially important new drugs and vaccines to treat or prevent serious conditions with ...
Health. Home & Garden
Fast Track designation is granted by the FDA to products under development that have the potential to treat serious conditions and fill an unmet medical need. It is designed to facilitate the clinical development and expedite the review of important new products with the intention to get them to the people who need them earlier 1 .
To get potentially lifesaving drugs to patients faster, the U.S. Food and Drug Administration is allowed to approve some drugs -- those that address unmet medical needs -- based on fewer trials ...