FDA Reopens Comment Period on PDUFA Reauthorization

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.

Electronic comments may be submitted to www.regulations.gov. — John Bechtel