GAO Analysis Says FDA is Meeting PDUFA Commitments

As explained in our summary of the 2017 reauthorization of PDUFA, for fiscal years 2018-2022, FDA has committed to reviewing 90 percent of new molecular entity (“NME”) NDAs in 10 months and 90 percent of new priority NDAs in 6 months of the filing date (60 days after actual submission); for non-NMEs, the review goals are 10 months and 6 months after submission, respectively.  At the direction of Congress, the GAO just released a new report evaluating exactly how FDA is doing in meeting these goals.