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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 ...
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 ...
1987 In May, the FDA approved the "first formulation of an opioid pain medicine that allowed dosing every 12 hours instead of every 4 to 6 hours"—MS Contin, morphine sulfate. [1] In 1995, Purdue Pharma laboratory tests showed that "68% of the oxycodone could be extracted from an OxyContin tablet when crushed". [10] [11]
FDA Advisory Committee Unanimously Recommends Approval of Gattex® (teduglutide) for Adults with Short Bowel Syndrome (SBS) -- Company also reports additional five patients achieved independence ...
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 ...
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 ...
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The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
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