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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 United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate endpoints . [ 1 ]
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 .
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 U.S. Food and Drug Administration (FDA) granted the application for beremagene geperpavec orphan drug, fast track, regenerative medicine advanced therapy, and priority review designations along with a rare pediatric disease priority review voucher. [3] The FDA granted the approval of Vyjuvek to Krystal Biotech, Inc. [3]
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 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.
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 ...