FDA track: PDUFA Performance

FDA

5 March 2020 - The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2017 (PDUFA VI), authorizes FDA to assess and collect fees for prescription drug products from October 2017 through September 2022. 

FDA dedicates these fees toward expediting the drug development process and the process for the review of human drug applications, including post-market drug safety activities. 

The Prescription Drug User Fee Performance Dashboards (PDUFA Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated FY 2019 PDUFA Performance Report to Congress for the Prescription Drug User Fee Act (the Report).

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Michael Wonder

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Michael Wonder