FDA User Fee Law Poised for Passage in Congress but Not Without Stirring Up Controversy
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FDA user fee law poised for passage in Congress but not without stirring up controversy.
T he fourth iteration of the 1992 law that allows the U.S. Food and Drug Administration to levy user fees on drug companies contains several reforms that could create a major change in how the agency monitors the safety of new drugs after they enter the market. Lawmakers are using reauthorization of the Prescription Drug User Fee Act (PDUFA) to overhaul the agency's authorities and responsibili...
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ژورنال
عنوان ژورنال: JNCI Journal of the National Cancer Institute
سال: 2007
ISSN: 0027-8874,1460-2105
DOI: 10.1093/jnci/djm071