Question: What is the Federal act that governs the speed of the regulatory review process for new therapeutic agents?
Answer: The cited article notes: “Although the 21st Century Cures Act which was signed into law in December 2016, includes several reforms that are intended to further streamline FDA evaluations, the speed of the regulatory review process is directed by the Prescription Drug User Fee Act (PDUFA).” (Downing NS et al. Regulatory review if new therapeutic agents- FA versus EMA, 2011-2015. 2017 NEJM, 376 (14): 1386-1387)
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