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# Stakeholder Participation Sought for PDUFA Reauthorization
- URL: https://www.fdaweb.com/stakeholder-participation-sought-for-pdufa-reauthorization/
- Published: 2020-07-07T12:00:00.000Z
- Updated: 2026-09-14T16:20:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147141

FDA is asking public stakeholders such as patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts to notify the agency if they intend to participate in periodic consultation meetings on PDUFA reauthorization. A *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-14585.pdf?ref=fdaweb.com) says PDUFA authorization expires 9/2022 and new legislation will be required for the agency to continue collecting user fees for the prescription drug program.

According to the notice, the Federal Food, Drug, and Cosmetic Act requires FDA to hold discussions at least every month with patient and consumer advocacy groups during its reauthorization negotiations with regulated industry.

“The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation,” the notice says.

Notification of intent to participate in the monthly online meetings should be submitted by 8/17.