This Week at FDA: HHS ends aborted fetal tissue research, PreCheck pilot update, 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 HHS ended research using aborted human fetal tissue and withdrew the US from the World Health Organization (WHO), and FDA published its 15^th annual novel drugs report.

The Department of Health and Human Services (HHS) announced that human fetal tissue from elective abortions would no longer be permitted for research use by the National Institutes of Health (NIH). “HHS is ending the use of human fetal tissue from elective abortions in agency-funded research and replacing it with gold-standard science,” HHS Secretary Robert Kennedy Jr., in a statement. “The science supports this shift, the ethics demand it, and we will apply this standard consistently across the Department.”

HHS and the Department of State announced that the US has completed its withdrawal from the World Health Organization (WHO) due to what the Trump administration said was the WHO's mishandling of the COVID-19 pandemic. The administration said the global health body delayed declaring the pandemic and praised China’s handling of the crisis despite evidence of information suppression.

As part of the Trump Administration's bid to strengthen the domestic pharmaceutical supply chain, FDA said manufacturers can start applying for its PreCheck Pilot Program beginning on 1 February. The program is intended to streamline the agency's oversight of certain manufacturing facilities based on national priorities, to provide greater regulatory predictability, and to encourage the construction of domestic factories.

FDA published its New Drug Therapy Approvals 2025 report, which states that it approved 46 novel drugs last year, of which 33 used an expedited program. It also noted that it approved 18 biosimilars, including 4 biosimilars for 3 new reference products.

FDA issued a request for information (ROI) on improving labeling and cross-contamination information regarding gluten in food products. More specifically, the agency said it wants detailed information on issues such as the prevalence of products in which rye or barley are not presently disclosed, the severity and potency of immunoglobulin E-mediated food allergy to rye and barley, and concerns about the gluten content of oats due to cross-contact.

FDA gave an initial review of the FDA ImportShield Program (FISP), formerly known as the Nationalized Entry Review Program, which is responsible for reviewing regulated import products. The program was launched in August 2025, and since then, the agency said that it has sped up product processing by 66%, increased monthly volume capacity by 33%, and reduced staff hours by 20%.

Drugs & Biologics

FDA published the latest minutes from its Generic Drug User Fee Amendments (GDUFA III) negotiations with the generic drugs industry from mid-December. Both sides touched on several issues, including a request from industry to make user fee cover sheets available by 1 August each year to accommodate industry administrative timelines. FDA countered the request by offering to make them available by 15 August.

Valneva has decided to withdraw its biologics license application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, Ixchiq, in the US. FDA suspended the vaccine's license in August 2025 and, more recently, told the company it had placed the IND on clinical hold while it investigates a newly reported foreign Serious Adverse Event (SAE).

The Reagan-Udall Foundation for the FDA will host a hybrid public meeting on Advancing Drug Development by Reducing Reliance on Animal Testing on 26 February. The organizations said that speakers will discuss how alternatives to rat testing, including FDA-supported New Approach Methodologies, may evaluate clinical safety without requiring unnecessary constraints on the progression of development programs.

Medtech

The Center for Devices and Radiological Health (CDRH) issued an early alert for Integra LifeSciences' MediHoney Wound and Burn products and certain lots of CVS Wound Gel after identifying packaging failures that could compromise the products' sterility. The agency said the company has sent letters to customers asking them to dispose of potentially faulty products.

An early alert was also issued for Olympus' High Flow Insufflation Units after the company reported to FDA that the products' software algorithm needs to be fixed to address a potential issue that could lead to overpressure events. The agency said that the products have been discontinued and are no longer supported, and the company has decided to remove them from the market.

This Week at FDA: HHS ends aborted fetal tissue research, PreCheck pilot update, and more

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