GDUFA IV: Commitment letter outlines key changes to program
Following months of negotiations with industry, the US Food and Drug Administration (FDA) has published its proposed commitment letter for the Generic Drug User Fee Amendments (GDUFA IV) program.
Among the changes proposed in the commitment letter are new initiatives to promote domestic manufacturing, a new meeting structure for applicants, and enhancements intended to reduce the number of review cycles it takes to get generic drugs approved.
The current GDUFA III program is set to expire at the end of September 2027 and must be reauthorized by Congress prior to then to avoid a lapse in FDA’s user fee funding.
FDA announced the release of the proposed letter in the Federal Register, along with details about an upcoming meeting to discuss these proposed changes, on Monday.
GDUFA IV
“The proposed enhancements for GDUFA IV address many of the top priorities identified by FDA, the regulated industry, and other stakeholders. These include proposed program enhancements to stabilize fee revenue, advance approvals in fewer review cycles, improve program efficiency, enhance processes around complex data issues, and provide mechanisms to facilitate onshoring of generic drug manufacturing,” FDA wrote in the Federal Register notice.
This onshoring proposal aligns with the Administration's objectives and Executive Order 14293 aimed at enhancing domestic manufacturing of essential medicines. In the negotiations, FDA has indicated that foreign fees have remained unchanged since the inception of GDUFA in FY 2013. The industry opposed the proposal, raising concerns that the fee hike may lead to companies leaving the US generic drug market. (RELATED: FDA proposes waiving GDUFA facility fees for domestic manufacturing, Regulatory Focus 5 February 2026)
According to the notice, “FDA is committed to encouraging domestic manufacturing to reduce supply chain risk. FDA proposes statutory changes to increase the foreign fee differential from $15,000 to $25,000 starting in FY 2028 for all foreign Active Pharmaceutical Ingredient (API), Finished Dosage Form (FDF) and Contract Manufacturing Organization (CMO) facilities.”
To encourage domestic manufacturing, FDA has proposed a statutory amendment to waive the application fee for the first three years for companies that establish manufacturing operations to produce finished generic drugs or APIs domestically.
In addition to these statutory changes, the FDA proposes that existing US generic API and FDF facilities lacking recent inspection history can request an inspection 24 months before a planned DMF or ANDA submission.
The proposal also introduces four new types of meetings between the industry and the agency: Type 30, Type 60, Type 90, and Type 120 meetings.
A Type 30 meeting allows the applicant to seek clarification on a previous interaction with the FDA or to discuss how a change to a product-specific guidance (PSG) may affect an ongoing ANDA program. A Type 60 meeting is intended for the applicant to request substantive follow-up on the same topic that was previously discussed with the FDA. A Type 90 meeting gives the applicant an opportunity to raise a new issue with the FDA, although it is limited to a single topic. Lastly, a Type 120 meeting is designed for the applicant to address multiple topics that require additional coordination with the FDA in order to provide a comprehensive response.
Other changes
Under GDUFA IV, ANDA applicants will use a pre-assigned ANDA number when submitting controlled correspondence to the agency. That way, the applicant does not have to submit copies of that correspondence and the agency’s response when submitting a subsequent correspondence.
FDA also proposes that, if it encounters a complex data issue in an application that cannot be fully assessed or resolved by the original goal date, it will establish a new goal date that is six months after the original. Furthermore, if this new goal date is not met, the FDA will reach out to the applicant and the relevant site or facility associated with the complex data issue to offer the opportunity for a meeting with the agency.
Additionally, the agency proposes to continue updating the Inactive Ingredient Database (IID) on an ongoing basis and to post quarterly notices regarding these updates. The proposed revisions include adding inactive ingredients that are newly and accurately identified in labeling approved by the FDA on or after 1 October 2027.
FDA plans to create a public Maximum Daily Dose (MDD) database, which will include at least 500 MDD values for reference listed drugs (RLDs) by the end of Fiscal Year 2028. The agency plans to keep updating this database with additional MDD values. Additionally, the FDA will seek public feedback on the usefulness of the MDD database.
The agency has proposed changes to expand the eligibility criteria for Drug Master File (DMF) prior assessments. This expansion would include complex active pharmaceutical ingredients (APIs) and prior approval supplements that aim to add a new API source located in the US.
Commitment letter; Announcement of public meeting
