Drug User Fee Goals Boost FDA Staff, Pick Up Key Pieces Of House Cures Bill

July 15, 2016 at 6:55 PM
FDA and the drug industry have agreed on performance goals for the sixth iteration of the drug user fee law that echo key objectives of the House-passed 21st Century Cures Act, including: enhancing adaptive, Bayesian and other clinical trial designs, incorporating the patient voice in drug development and enhancing the review of combination products. FDA, in unveiling the goals Friday (July 15), also committed to boost its hiring capabilities. The performance goals reassert the agency's stance that enhancements to the...


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