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PDUFA date. In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. [1] It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and ...
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to ...
Signed into law by President George H. W. Bush on October 29, 1992. The Prescription Drug User Fee Act ( PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to ...
July 2, 2024 at 4:01 PM. By Julie Steenhuysen and Mariam Sunny. (Reuters) -The U.S. Food and Drug Administration on Tuesday approved Eli Lilly's treatment for early Alzheimer's, making it the ...
August 8, 2024 at 10:55 AM. By Mariam Sunny. (Reuters) -The U.S. Food and Drug Administration has approved Citius Pharmaceuticals' therapy for patients with a form of blood cancer who have ...
Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.
By Leroy Leo. (Reuters) - Guardant Health said its blood test to detect cancer that starts in the colon or rectum got an approval from the U.S. Food and Drug Administration, with the test moving ...
t. e. 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.