08/24/2021
Photo by Myriam Zilles on Unsplash
The US Food and Drug Administration (FDA) is holding a public meeting to discuss recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA). Stakeholders are invited to discuss their opinions on recommended enhancements for the next reauthorization. PDUFA began in 1992 and must be reauthorized every five years. Starting in 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) included the fifth reauthorization of PDUFA and the third reauthorization of the Medical Device User Fee Act (MDUFA), which began in 2002. PDUFA provides funding to the FDA for faster regulatory review of new drugs or biologics and MDUFA does the same for new medical devices. Although the fees look large, a delay in review can cost the sponsor company even more in lost revenue. Reauthorization is required for the FDA to continue to collect user fees to fund their review, and the current PDUFA authorization will end in September 2022.
Topic: FDA Public Meeting to discuss proposed recommendations for the reauthorization of the PDUFA for fiscal years 2023 through 2027
Date: September 28, 2021
Time: 9:00 a.m. to 2:00 p.m. ET
Register for the public meeting HERE.
Request to make a verbal comment with the link here: https://www.surveymonkey.com/r/QP2WDWJ
Add a public comment to the enhancements HERE to docket FDA-2021-N-0891, which will be published before the public meeting. Comments accepted through October 28, 2021.
- The Clinical Pathways Team
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