This Week at FDA: User fee commitment letters, new HHS regulatory agenda, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA published its proposed commitment letters for the Prescription Drug User Fee Act (PDUFA VIII) and Generic Drug User Fee Amendments (GDUFA IV) programs, the Department of Health and Human Services (HHS) posted its semiannual regulatory agenda to the Federal Register, and FDA released several guidance documents, including a draft guidance on container closure systems for drugs and biologics.
FDA’s proposed recommendations to the PDUFA program include changes to premarket review, postmarketing evaluation, financial management, information technology, and chemistry, manufacturing, and controls (CMC). The commitment letter also proposes to remove some elements of PDUFA VII, such as the Split Real Time Application Review (STAR) pilot and the CMC Development and Readiness Pilot (RELATED: PDUFA VIII: FDA outlines goals, program enhancements in commitment letter, Regulatory Focus, 13 August 2026).
The GDUFA IV commitment letter proposes changes to elements of the program that relate to fee revenue, advance approvals, program efficiency, data processing, and offshore generic drug manufacturing. Other proposed changes include potential waivers to abbreviated new drug application (ANDA) submission fees for exclusively using finished dosage form (FDF) manufacturers and the API suppliers in the US, and four new meeting types between applicants and FDA (RELATED: GDUFA IV: Commitment letter outlines key changes to program, Regulatory Focus, 12 August 2026).
HHS published its semiannual regulatory agenda today, adding a proposed rule from the fall of 2024 that would amend the good laboratory practice regulations to require a modern quality system, and another proposed rule that would remove the option for prescription drug advertisements to disclose risks outside of the advertisement. The regulatory agenda also moved a proposed rule that would change medication guide regulations to the final rule stage.
The Office of Management and Budget received a final rule to review on the development of cell and gene therapies. The rule would serve as a document that answers common questions industry stakeholders may encounter when developing these products involving regulatory review, CMC, pharmacology and toxicology, clinical, and clinical pharmacology.
The Centers for Medicare & Medicaid Services (CMS) is asking for feedback on its Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. RAPID would allow for same-day national coverage determination following a marketing authorization, reducing the time before Medicare could cover breakthrough medical devices authorized through the pathway.
FDA published two guidance documents this week: a draft guidance document on evaluating container closure systems for drugs and biologic products—including closure systems in combination products and used in packaging drugs and biologics—and a final guidance document outlining formal meetings between sponsors and applicants and the agency for PDUFA products. FDA elaborated on additional Type D meeting scenarios, added more information about INTERACT meetings, and provided more information on meeting formats to the final guidance.
Drugs and Biologics
FDA issued a complete response letter to ITM Isotope Technologies for its investigational agent intended to treat gastroenteropancreatic neuroendocrine tumors, citing manufacturing issues as the reason why it rejected the new drug application. The agency said there were no clinical or safety concerns with the application.
A new multiple myeloma therapy, iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone, was approved by FDA on 13 August under its accelerated approval pathway. The agency conducted the review with Swissmedic under Project Orbis.
Fresenius Kabi has issued a recall for Tyenne (tocilizumab-aazg), an Actemra biosimilar, after an internal investigation identified glass particles in the product’s vials. The recalled product was shipped in March 2026 and was distributed nationwide, the company said.
Kremers Urban Pharmaceuticals, Inc. has been granted an evidentiary hearing on a proposal to withdraw approval of an ANDA for methylphenidate hydrochloride extended-release tablets. The Federal Register notice states the FDA Center for Drug Evaluation and Research (CDER) first published the notice of opportunity for hearing on the withdrawal proposal for the application in October 2016, and the company “submitted a timely request for hearing on that proposal.”
FDA also published a trio of notices this week with determinations that Ansaid tablets, Lasix tablets, and Ozobax oral solution were not withdrawn from sale due to concerns over safety and effectiveness. The agency said it would not withdraw approval of applications that refer to these products and would continue to approve applications that would refer to these products if usual regulatory requirements were met.
Medtech
HHS and FDA announced a proposal to reclassify digital breast tomosynthesis systems from class III to class II devices. FDA proposed these systems also receive a new device classification, “Digital Breast Tomosynthesis System.” The agency said in its Federal Register notice that the new device classification will help “identify these devices along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.”
Medline has issued a correction for its recall of convenience kits that contain ICU Medical, Inc. pain management kits, stating customers should not use the bupivacaine hydrochloride in the kits and complete a recall response form to receive over-labels for the kits. FDA initially issued an early alert for the Medline convenience kits that referenced a different recall.
FDA announced a correction for Abiomed and manufacturing partner Oscor’s catheter introducer for their line of heart pumps. The agency said that hospitals may continue using the product, but should perform a device exchange or use a repositioning sheath if leakage from the device’s sidearm is observed. The companies initially issued the correction announcement in June 2026.
Hamilton Medical has issued a recall of breathing circuit sets from certain ventilators be removed due to a potential risk of the valve membrane on the breathing circuit set is adhered to the sealing ring, which can impede the flow of expiratory gas.
Baxter has issued a recall of its Duo-Vent solution set, citing a risk of air bubbles in the drip chamber and tubing when pressure is applied to the bag or tubing. This may cause air to be delivered into the infusion line during pressure infusions, which can pose a risk to patients with certain cardiovascular conditions.
