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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 ...
FDA v. Wages and White Lion Investments, L.L.C. 23-1038: Whether the U.S. Court of Appeals for the 5th Circuit erred in setting aside FDA’s denial orders of respondents' applications for authorization to market new e-cigarette products as arbitrary and capricious. July 2, 2024: Feliciano v. Department of Transportation: 23-861
Commissioner of Food and Drugs. The United States commissioner of food and drugs is the head of the Food and Drug Administration (FDA), an agency of the United States Department of Health and Human Services. The commissioner is appointed by the president of the United States and must be confirmed by the Senate.
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The company's lead product, Gattex ® 0.05 mg/kg/d (Teduglutide [rDNA origin]) for Injection is FDA-approved for the treatment of adult patients with short bowel syndrome (SBS) who are dependent ...
Blue Belt already received European CE Mark approval back in February, so the company's passed its two first major regulatory hurdles. ... The article The FDA Approval MAKO Investors Need to Know ...
Originally available only by prescription, it was approved by the FDA for over-the-counter sale in February 2007. In May 2010, the U.S. Food and Drug Administration (FDA) approved a revised label for Xenical to include new safety information about rare cases of severe liver injury that have been reported with the use of this medication.
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