This Week at FDA: FDA’s leadership churn continues, PDUFA negotiations wrap up, 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, we learned of additional leadership turnover at the agency, including new acting chiefs for the agency’s drug and biologics centers, and the agency announced that it has concluded negotiations with industry to reauthorize its prescription drug user fee program.

After last week's news that both FDA Commissioner Marty Makary and Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research (CDER), were pushed out, a slew of additional leadership changes have been announced. In an email to staff last Friday, acting FDA Commissioner Kyle Diamantas announced that Michael Davis would serve as acting CDER director, Karim Mikhail would serve as acting director for the Center for Biologics Evaluation and Research (CBER), and Lowell Zeta would serve as acting chief of staff after Jim Traficant was ousted from that position last week.

While the dust is still settling, Beth Høeg told MD Reports that she first learned about her firing from news media reports and thought they were just rumors until two FDA officials came to her office demanding that she either resign or be fired.

Bloomberg News also reported that FDA Deputy Chief of Staff Sam Doran and Chief AI Officer Jeremy Walsh also left the agency last week.

FDA published several guidance documents, including a final guidance that aligns its clinical electronic structured harmonized protocols (CeSHarP) with the M11 template guidance and the technical specification requirements set by the International Council for Harmonization (ICH). It also published a final guidance on conducting protein efficiency ratio (PER) rat bioassay studies for infant formulas.

Furthermore, FDA published dozens of draft and revised draft product-specific guidances that address the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). They include 23 draft and 48 revised draft product-specific guidances.

Drugs & biologics

External experts on FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss recommending Moderna's MFLUSIVA (influenza vaccine) on 18 June, which had initially received a refuse to file (RTF) letter due to objections from Prasad, but was allowed to move forward after political and industry pushback. The vaccine is intended to prevent disease caused by the influenza virus subtypes A and B, as represented in the vaccine, for people 50 years and older.

FDA's FAQ website for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot for digital health devices has been updated to include an educational module. The agency said the module will enable stakeholders to learn about the pilot's goals and features, what information to submit to participate, and the pilot selection process.

FDA published minutes from its 15 May meeting with drug industry groups negotiating the next Prescription Drug User Fee Amendments (PDUFA VIII) deal, in which the agency said it had concluded technical negotiations with industry.

Medtech

Stakeholders have until 18 June to submit their proposals for the 2026 cycle of FDA's Experiential Learning Program (ELP), which allows staff at the Center for Devices and Radiological Health (CDRH) to participate in training visits and learn about emerging and innovative technologies being developed by industry. While stakeholders can offer training in any areas of interest, the agency has listed its own areas of interest, including Home as a Health Care Hub, device manufacturing and validation, and artificial intelligence/machine learning (AI/ML).

Trividia Health has issued an updated urgent medical device correction notice for its TRUE METRIX blood glucose monitoring systems, according to FDA. The company issued a recall in February for the devices due to concerns about the product's software and says it is working to update the software.

Bolton Medical has issued a Class I recall removing certain RelayPro Thoracic Stent-Graft Systems from the market due to concerns that, in some instances, the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. The company has reported three deaths associated with the issue and has advised users to consider using an alternative stent-graft system.

React Health has also issued a Class I recall for certain of its VOCSN V+Pro ventilators due to concerns that a manufacturing defect may cause undetected oxygen leaks, according to FDA. The company has advised customers to stop using the affected devices.