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# America First Fee Incentives Discussed in PDUFA Meeting
- URL: https://www.fdaweb.com/america-first-fee-incentives-discussed-in-pdufa-meeting/
- Published: 2026-04-09T12:00:00.000Z
- Updated: 2026-09-14T13:37:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160960

At the 3/10 meeting of the PDUFA 8 reauthorization steering committee, industry responded to FDA’s perspectives on the America First fee incentives proposal. Meeting [minutes](http://www.fda.gov/media/191794/download?attachment&ref=fdaweb.com) indicate that the two sides discussed that, contingent on FDA and industry agreeing to eligibility criteria for applications with Phase 1 clinical trials anchored in the U.S., FDA and industry agree with the fee incentives proposal outlined at a previous meeting, in which qualifying applications would pay half of the application fee. Industry agreed to propose criteria for applications with Phase 1 clinical trials anchored in the U.S.

At the 3/12 meeting, the industry [shared](http://www.fda.gov/media/191798/download?attachment&ref=fdaweb.com) its proposed definition for anchoring Phase 1 clinical trials in the U.S. and qualifying for the fee incentive. The agency shared initial responses to the proposal and highlighted feasibility concerns associated with verifying the eligibility criteria.

Industry raised questions about how INDs that attempted to meet the proposed criteria but were placed on clinical hold would be handled. Industry also inquired about how an applicant would provide documentation to show that they meet the eligibility criteria. Industry agreed to revise its proposed eligibility criteria in response to the discussion, and FDA agreed to consider how sponsors might verify that they meet the criteria.

Also discussed at both sessions was a non-orphan indication supplement fee proposal. FDA agreed to draft language reflecting its acceptance that the fee assessed for the first supplement seeking to add a non-orphan indication to an application approved for an orphan indication should be half of the application fee.