The FDA and industry representatives reported on two more negotiation sessions held on March 4, 2026 and March 6, 2026, the minutes of which are reported in full here and here, respectively. There was some progress—agreements were made on certain topics, and discussions were foreclosed on others—but it looks like we are getting closer to an agreement on a commitment letter for a new five-year iteration of GDUFA. Some of the important issues are addressed below.

Maximum Daily Dose (MDD)

It is clear that the FDA and industry agree that there is need to provide additional information on the issue of MDD calculations for the purposes of establishing daily maximum exposure for inactive ingredients. The FDA agreed to develop a database and “populate the database with at least 500 {MMD] values by the end of FY 2028, and by the end of FY 2030, it would assess the resources needed to provide and maintain a full coverage database.” The FDA also agreed to solicit public comments on the type of products that should be included in the first set of values as calculations of MMDs for certain products provide unique challenges.

Inactive Ingredients Database (IID)

After some back and forth, the FDA and industry agreed on revised language for the commitment letter regarding updates to the IID.

Drug Master Files (DMF) Prereview

There were still considerable discussions and negotiations surrounding this topic and the impact of deficiencies and Information Requests (IRs) that may be outstanding at the time of ANDA filing. The “FDA indicated that it does not anticipate that these IRs related to the DMF prior assessment would impact the filing of the ANDA. FDA also noted that if there are ongoing concerns among industry about the timing of IRs, the agency is still open to its original proposal in which requests for DMF prior assessment (for non-complex) could generally be submitted five months prior to the planned submission date for the linked ANDA and IRs would be provided at the planned ANDA submission date.” This issue has not yet been resolved.

Pre-Launch Activities Importation Requests (PLAIR) Process

While industry kept pressing for a workshop on expanding the scope of Plair program, the “FDA indicated that the agency is not open to addressing a possible expansion to the PLAIR program or a workshop through negotiations, as this is broader than GDUFA. FDA noted its earlier point that eligibility for this program is outlined in FDA’s final guidance (the specific content of which the agency does not negotiate) and that the appropriate channels for submitting questions about or suggested changes to the PLAIR program is via the guidance docket or to the office responsible for PLAIR.” Industry withdrew its proposal.

ANDA Meeting Program and Controlled Correspondence

The FDA and industry got to a place of close agreement on the points raised regarding this topic, with the FDA agreeing to provide proposed commitment letter language at the next meeting.

In the March 6th negotiation meeting, the FDA provided feedback to industry from the February 10th stakeholders meeting (see minutes of the March 6, 2026 at the link above).

Prioritization MAPP

Industry indicated alignment with the most recent counterproposal. The FDA agreed to draft commitment letter language.

Maximum Daily Dose (MDD) Language

Industry proposed modifications to commitment letter language for the MDD enhancement. The FDA indicated agreement with the changes.

Forfeiture Determinations

There is still nonalignment on the issue of timing and circumstances under which the FDA could provide forfeiture determinations. While both sides may be getting closer, the Agency would still need to discuss the revised proposal internally. Agreement on the issue was still not reached.

Meetings Commitment Letter Language

The FDA and industry are getting close on this topic but industry asked clarifying questions and agreed to provide revised language at the next meeting.

On a topic unrelated to these negotiations, industry “raised concerns about the recently announced Reviewer Recognition & Excellence Program (RREP) program to provide bonuses to reviewers and asked about implications on the GDUFA program’s financial predictability and operating reserve.” The FDA noted that bonuses have historically been “paid with a mix of user fees and budget authority” and, thus, the Agency “does not expect large impacts on payroll or operating reserve.”

That’s it for now! While the negotiations are getting close, remember the devil is always in the details!