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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]
And 1 in 3 adults ages 65 and older dies with it or another form of dementia, ... FDA approval of Leqembi: U.S. Food and Drug Administration Leqembi study: New England Journal of Medicine
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 ...
(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday approved two close copies of Regeneron Pharmaceuticals' Eylea, its first-ever clearance to biosimilar versions of the blockbuster ...
In its Q4 and 2012 results today, Novartis announced that net sales grew 2% year-over-year on a constant currency basis to $14.8 billion during the quarter, while net income advanced 5% to $3.1 ...
The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market.