FDA's 195-entry PREA table signals tighter pediatric enforcement

A 195-entry non-compliance table published by FDA under section 505B(d)(1) of the FD&C Act is the clearest signal yet that pediatric postmarketing timelines are under active enforcement scrutiny, regulatory affairs leads managing PREA commitments should treat the list as a live compliance benchmark, not a historical archive.

FDA publishes 195-entry PREA non-compliance letter table

The table, maintained on FDA's development resources page, identifies drug and biological product sponsors that have received formal Non-Compliance letters for failing to submit required pediatric assessments or reports of molecularly targeted pediatric cancer investigations within mandated timeframes. Letters are also issued where sponsors have not requested approval for a pediatric formulation as required under sections 505B(a) or 505B(b) of the FD&C Act. Both the letters and sponsor responses, redacted for trade secret or confidential commercial information, are publicly posted consistent with statutory requirements.

Recent entries span a range of therapeutic categories and sponsor sizes. Among the 2025–2026 additions: Tris Pharma (Onyda XR, clonidine hydrochloride extended-release oral suspension), Teva Pharmaceuticals (Alvaiz, eltrombopag tablets), Azurity Pharmaceuticals (Eprontia, topiramate oral solution, appearing twice), and Harrow Eye (IHEEZO, chloroprocaine hydrochloride ophthalmic gel), which had submitted no response as of the table's publication date. Shionogi's Fetroja (cefiderocol) received a deferral extension on December 8, 2025, following an October letter, illustrating that the deferral-extension pathway under section 505B(a)(4)(B)(i) remains available but must be requested by the assessment due date to prevent letter issuance.

FDA's procedural framework is precise: if a sponsor requests a deferral extension or submits a waiver under section 505B(a)(5) by the due date, no non-compliance letter is issued unless FDA subsequently denies the request. Where FDA determines a letter was issued in error, for example, because a waiver was granted before the due date, neither the letter nor the sponsor's response is posted. Fulfilled or released requirements are annotated with a completion date in the table's final column.

Where regulatory affairs teams should re-examine PREA timelines

The breadth of the current table, spanning small biotechs, generic manufacturers, and established brand sponsors, indicates that no segment of the industry is operating outside enforcement reach. For regulatory affairs leads, the immediate action is a structured audit of all open PREA postmarketing requirements against their committed due dates, cross-referenced with FDA's Postmarket Requirements and Commitments database.

Sponsors with deferred pediatric assessments approaching their due dates should confirm whether a deferral extension request is warranted and, critically, that it is filed before the assessment deadline rather than after a non-compliance letter has been issued. The Shionogi/Fetroja entry demonstrates that a post-letter deferral extension can be granted, but the public record of non-compliance remains. For sponsors managing multiple PREA commitments across a portfolio, a single missed deadline on one product can generate a publicly visible entry that persists in the table even after the requirement is fulfilled.

QA directors and regulatory operations teams should also note the response-time pattern visible in recent entries: sponsor responses have generally arrived within three to six weeks of letter issuance. An absence of response, as seen with Harrow Eye's IHEEZO entry, is itself a data point FDA retains in the public record.

Upcoming PREA deadlines and the deferral extension window to track

Sponsors with pediatric assessments due in the second half of 2026 should be mapping their submission timelines now. The statutory deferral extension pathway under section 505B(a)(4)(B)(i) requires proactive engagement, requests filed after a due date has passed do not prevent letter issuance. For molecularly targeted pediatric cancer investigations, the same pre-deadline discipline applies.

FDA's Postmarket Requirements and Commitments database remains the authoritative source for tracking the current status of individual PREA requirements, including whether a deferral or waiver is on file. Regulatory teams should treat the non-compliance table as a parallel monitoring tool, reviewing new entries as they appear to benchmark enforcement patterns and response expectations.

With the table now at 195 entries and recent additions spanning early 2026, the next quarterly update will indicate whether FDA's issuance pace is accelerating, a metric regulatory affairs leads should track alongside their own portfolio deadlines.