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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.
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 ...
The U.S. Food and Drug Administration (FDA) granted the application for sotorasib orphan drug, fast track, priority review, and breakthrough therapy designations. [5] [10] The FDA granted approval of Lumakras to Amgen Inc. [5] Sotorasib was approved under the FDA's accelerated approval program. [19]
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.
Small-cap cancer researcher GTx announced Tuesday that the U.S. Food and Drug Administration has granted "fast track" development status to its enobosarm (GTx-024) drug for the prevention and ...
The FDA grants a Fast Track designation to Spectrum Pharmaceuticals' (SPPI) poziotinib for treating non-small cell lung cancer in previously treated patients with HER2 exon 20 mutations.
A "qualified infectious disease product" is defined as an antibacterial or antifungal drug intended to treat serious or life-threatening infections. It requires the FDA to establish and maintain a list of pathogens qualifying for the program and makes qualified infectious disease products eligible for priority and fast track review. [2]