FDA Reopens Comment Period on PDUFA Reauthorization
Wednesday, October 21, 2015
Source: FDA News
The FDA is reopening the comment period on reauthorization of the Prescription Drug User Fee Act until April 29, 2016.
PDUFA V is set to expire in September 2017, and PDUFA VI will set user fees and review goals for fiscal years 2018 through 2022. The original comment period ended Aug. 15, following a public notice in May and a public hearing in July.