President Signs Law Reauthorizing Drug and Device User Fees: Legislation Contains Several Important FDA Reforms


On Monday, July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). This statute reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA), which provide a significant portion of FDA’s funding for new product application review. In addition to reauthorizing these user fees, FDASIA includes a number of provisions affecting FDA regulation of drugs and medical devices. Several of the most controversial proposals ultimately were not included in the legislation, including a provision that would have established a national “track and trace” program for drugs and a provision that could have delayed FDA’s ability to regulate mobile medical devices. This alert briefly summarizes the law’s most important provisions.

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