FDA calls for stakeholders to join GDUFA talks

Regulatory NewsRegulatory News | 10 September 2020 |  By 

The US Food and Drug Administration (FDA) this week called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Generic Drug User Fee Amendments (GDUFA III) program.
The call comes less than two months after the agency held its GDUFA III reauthorization kickoff meeting, during which industry stakeholders sought improvements to the generic drug approval process, including for complex generics. (RELATED: FDA kicks off GDUFA III reauthorization process, Regulatory Focus 21 July 2020).
With the current GDUFA program set to expire in September 2022, FDA and industry are gearing up for the negotiations that will inform any refinements or changes to the current program. Alongside those discussions, FDA will hold monthly stakeholder meetings beginning next month.
During the previous GDUFA reauthorization process there were eight stakeholder meetings, 28 industry negotiation sessions, six meetings on fee modeling and four small business group meetings.
FDA is asking that stakeholders, including patient and consumer advocacy groups, notify it of their interest to participate in the meetings by 8 October. Due to the coronavirus disease (COVID-19) pandemic, the meetings will be held virtually.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy