The ongoing GDUFA IV negotiations have shed some light on interesting issues that will apply to the new GDUFA reauthorization period for FYs 2028 to 2032 presently being considered by both industry and the FDA. The full minutes of the February 19, 2026 FDA-industry negotiation meeting can be found here, but I have a brief summary of the goings-on for you today.
Some of the topics discussed include industry’s request to expand the Drug Master File (DMF) prior assessment enhancements. The FDA noted that expansion to include all DMFs is not feasible, but did note that it would consider a prior assessment expansion for eligibility that would “include assessment of DMFs that have not previously been reviewed in advance of the following types of ANDA submissions: planned ANDA submissions for which all patents and exclusivities will expire within 18 months of the planned submission date; planned PASs including reference to a DMF in which a new domestic API source is added; and planned submissions for complex APIs.” The FDA also proposed limits on the number of DMFs that it would include in the prior assessment program due to perceived resource constraints. No agreements were made, but both sides are still reviewing the proposals on the table.
Industry had asked for a 45-day filing review for structured review changes (down from the current 60-day timeframe). The FDA said it would consider this if industry would shorten the response to FDA information requests on the initial completeness review of an ANDA from ten to seven calendar days, but industry wanted to propose seven business days. There was also a discussion of the timeliness for the FDA to send internal consult requests, and the FDA noted that sometimes it isn’t possible to anticipate the need for a consult during the initial filing review until either a firm responds to an information request or until the reviewer has an opportunity to evaluate data during the substantive review of the ANDA. There was also a discussion of the 90-day goal date extension and industry’s request for a single 90-day extension. The FDA noted that this could lead to more minor amendment Complete Response Letters. The FDA offered an alternate solution (see meeting minutes), and both sides seemed to be narrowing in on a potential agreement, but additional discussion would be necessary.
The Imminent Action provision was under discussion, and industry had asked for some clarification to be contained in a MaPP or guidance document. Industry also asked whether a 90-day extension would be appropriate when an inspection is pending classification. The FDA noted that the Agency’s separate proposal to address potential Official Action Indicated (pOAI) alerts is the better option for addressing this issue.
The issue of missed goal dates and the industry’s desire for reporting metrics on missed goal dates was discussed.
The FDA and industry seemed to agree on how and when the FDA would make an initial review of drug product labeling and subsequent review timelines when an innovator revises its labeling. The FDA agreed to try to complete these reviews within 30 days of receipt of the revised labeling, but only for package-insert prescribing information.
There was also some discussion centered on the FDA’s proposal to standardize certain information in ANDA submissions. Industry wanted to know whether that could reduce costs by reducing full-time employee (FTE) hours. The FDA claimed that it would aid “industry in providing more complete and readily identifiable information in their submissions, which can help reduce information requests and allow for identification of needed consults earlier and noted that this is expected to translate to faster time to approval but would not necessarily translate to FTE savings.” However, no agreement was made on this issue.
The issue of the use of post-marketing commitments was brought up again by industry, but once more it was shot down by the FDA (even though other FDA components use this as a routine provision in application approvals). The FDA noted that in benefit-risk determinations there are “differences across product types in potential benefits, particularly those offered by certain innovator products. Separate from the benefit-risk framework, FDA observed that while multiple ANDA applicants commonly submit applications for the same product on the same date, this has not occurred to-date for biosimilar applications.” Industry decided to throw in the towel on this point. For example, the FDA noted the concerns that could arise about treating similarly situated entities fairly if an applicant requested use of a quality postmarketing agreement (QPA) in lieu of providing certain information for their proposed drug product pre-approval when other applicants with pending ANDAs for the same drug product had provided that information pre-approval.
There was a discussion of forfeiture of exclusivity for failure to obtain tentative approval within 30 months. Industry had wanted the FDA to make such a determination within 90 days after the 30-month period, but the FDA noted that there are too many fact-specific issues that must be taken into account, and the fact pattern can change over time, which would make it impossible for the FDA to make a decision until it absolutely has to.
That’s about it for now, but you might also want to look at the minutes of the financial negotiation sub-meeting here for a flavor of the proposals surrounding the fee structure for GDUFA IV.
