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# PDUFA Talks Hit Snag on Review Timelines/Transparency
- URL: https://www.fdaweb.com/pdufa-talks-hit-snag-on-review-timelines-transparency/
- Published: 2025-12-18T12:00:00.000Z
- Updated: 2026-09-14T15:29:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160415

FDA officials and pharmaceutical industry representatives are at odds over how far to go in formalizing review timelines and expanding transparency as negotiations continue over the next reauthorization of the Prescription Drug User Fee Act, according to [just-released minutes](https://www.fda.gov/media/190232/download?attachment&ref=fdaweb.com) from an 11/18 meeting.

During a two-hour virtual session, FDA officials and industry representatives sought to resolve outstanding questions on agency proposals related to meeting management and rare disease programs, while beginning negotiations on industry’s push to “facilitate first-cycle review” of drug applications.

A central point of disagreement emerged over industry’s proposal to introduce interim performance metrics aimed at reducing delays in first-cycle reviews and approvals. FDA said it does not anticipate creating or accepting new metrics beyond existing guidance laid out in internal policies, arguing that interim milestones are intended as flexible guides rather than enforceable benchmarks.

Industry representatives countered that delays in first-cycle reviews are a growing problem and said additional reporting could help identify bottlenecks without imposing new burdens, noting that many timelines are already documented in FDA manuals and procedures. The two sides agreed to continue negotiating the issue in future meetings.

FDA and industry tentatively found common ground on another proposal calling for a third-party assessment of the application review process at CDER and CBER. The assessment would focus on the causes of Complete Response letters and factors contributing to extensions in first-cycle review timelines, though details remain under discussion.

Both sides acknowledged that IND protocol submissions remain a pain point, but they diverged on how to address it. Industry cited examples in which FDA feedback arrived after pivotal trials had already begun, complicating development programs and contributing to downstream delays. FDA responded that not all protocols require agency input and pointed to existing guidance intended to support protocol design.

Negotiators also raised concerns about late information requests, inter-Center consults for combination products, and inspection timing, all of which industry said can push reviews beyond PDUFA deadlines and increase the likelihood of Complete Response letters. Several of those topics will be taken up by other PDUFA subgroups focused on chemistry, manufacturing, and controls.

Another unresolved issue is industry’s request that FDA routinely publish redacted action packages for all approved NDAa/BLAs, and efficacy supplements. FDA said resource constraints prevent such broad disclosure and noted that it already prioritizes posting action packages for new molecular entities and original biologics within weeks of approval.

Agency officials suggested companies could seek additional materials through Freedom of Information Act requests, while industry representatives argued that broader publication would improve understanding of FDA decision-making and benefit future development programs. Talks on transparency will continue, the minutes noted.