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This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
Before we jump in, make sure to catch our recent conversation with former two-time FDA Commissioner Dr. Robert Califf, who shares his perspectives on what it will take to see population-level benefit from GLP-1s:
FDA Leadership and Administration
Overton faces the HELP Committee: Heidi Overton, the president’s nominee for FDA commissioner, appeared before the Senate Health, Education, Labor and Pensions Committee on September 24 for her confirmation hearing. Senators questioned her mainly about vaccine safety, mifepristone availability, FDA decisions on vapes, and food safety oversight, and some of the toughest questions came from Republican members. In her opening remarks, Overton said that if confirmed, she would “work with the dedicated career professionals to make sure every aspect of clinical trials and drug development is optimized.” She also said she would take the recommendations of career staff on product determinations, and she called advisory committee meetings a “critical part” of the FDA’s processes. “I think they are extremely valuable from everything that I know about the FDA,” she said.
FDA plans a new associate commissioner role: The FDA announced its intent to hire an associate commissioner for regulatory policy coordination, a position that appears to be new to the agency. The person would report to Grace Graham, the FDA’s deputy commissioner for policy, legislation, and international affairs. The role would be heavily involved in drafting new regulations and policies and moving them through the agency’s internal approval process.
HR shortages slow FDA hiring: STAT News reported that the FDA’s efforts to hire new staff are being slowed by a shortage of HR personnel to process applications. As a result, would-be hires are stuck in what the report called “pre-onboarding limbo.” The FDA’s HR staff now works under a “shared services” model, which has created further problems affecting all product centers. The FDA’s workforce has shrunk, and the agency is now trying to staff up to meet urgent needs.
Acting commissioner invited to the next MAHA Summit: Acting FDA Commissioner Kyle Diamantas has been invited to discuss FDA modernization with White House policy advisor Calley Means at an upcoming Make America Healthy Again Summit, which was announced in mid-September. The summit will also include a session on psychedelic medicine with HHS Deputy General Counsel Matt Zorn and the CEOs of three biotech companies. One of those companies, Compass Pathways, received a Commissioner’s National Priority Voucher in April.
Kennedy says he remains committed to changing vaccine policy: 💊 HHS Secretary Robert F. Kennedy Jr. told Children’s Health Defense, the advocacy group he founded and previously led, on September 17 that he remains committed to changing how the federal government reviews and recommends vaccines. “I intend to stay in this fight as long as I am able,” Kennedy said in his keynote address. He also asked for patience as he works through administrative procedures and legal requirements, saying, “In government, a bunch of things have to happen before something else happens or you get sued.” Kennedy referenced recent executive orders on vaccines and called President Trump an ally of the organization.
Trump calls for splitting childhood vaccine doses: 💊 President Trump said at the White House on September 18 that he will be “demanding” vaccine makers sequence their products into more shots with smaller doses, a change that could require developers to submit new formulations to the FDA for approval. Trump said the administration would recommend five doses at 20% strength, given at six-month intervals, and would split up some vaccines. He also said the administration would remove “certain vaccines that people are a little worried about” from recommended schedules. Trump said he believes these changes will result in a “massive reduction in autism.”
HHS seeks information on electromagnetic field exposure: 💉 HHS issued a request for information on September 18 on the human health effects of electromagnetic field exposure, including radiofrequency radiation and radiation from wireless sources. HHS said the responses will help it assess the current scientific evidence, compare domestic and international safety standards, identify research gaps, and inform recommendations for policymakers, schools, and families. The RFI appears to focus mostly on consumer goods. Two citizen petitions filed with the FDA in June and August, however, raised safety issues for magnetic resonance imaging products.
HHS will forecast its PPE purchases: 💉 HHS announced a new system to forecast its demand for personal protective equipment. The project, led by the Office of the Assistant Secretary for Financial Resources, will be “the first official, recurring process to identify, consolidate, and publish anticipated HHS purchases of personal protective equipment.” HHS said the goal is to give American PPE manufacturers “a clearer and more predictable signal of future HHS demand.” The first forecast is due October 15, with quarterly updates after that.
Executive order creates America.gov: President Trump signed an executive order on September 29 directing the creation of America.gov, a single website where the public can access government services and information. The order describes the site as a secure point of entry where people can sign in, ask questions in plain language, get answers, and, where possible, complete government transactions without visiting multiple agency websites. The FDA runs many consumer-facing forms, including adverse event reporting, and it is not yet clear how the agency will apply the order to them. The Office of Management and Budget is expected to issue implementation guidance to agencies within 90 days.
FDA General
IND pilot could lead to an Australia-style trial system: 💊 The FDA has asked Congress to create a “clinical trial notification” system modeled on Australia’s risk-based framework, and agency leaders said on September 15 that the new expedited IND pilot could serve as a bridge to it. Speaking at an Endpoints News event, Deputy Commissioner Grace Graham said the pilot, which will start with eight to 10 pairs of drug sponsors and research institutions, would give the FDA “a better sense of what to look for” in third parties if Congress grants that authority. CBER Director Karim Mikhail said Australia’s system depends on its human research ethics committees, which oversee some low-risk trials directly. If qualified research institutions can speed research with fewer clinical holds, Mikhail said, “then we know we have a case that hopefully we can evolve to a CTN one day.”
Graham outlines PDUFA VIII priorities: 💊 The 54-page draft commitment letter for the next Prescription Drug User Fee Act was the focus of a September 16 public meeting, where FDA Deputy Commissioner Grace Graham said the recommendations center on America First, manufacturing, and rare disease. Graham pointed to a proposed cut in application fees for companies “anchoring” Phase 1 trials in the U.S. She said the negotiations gave the agency “a great window” into how it can improve its processes so the chemistry, manufacturing, and controls portion of applications is not “a lagging indicator.” She also highlighted plans to fold several pilot programs, including the Rare Disease Endpoint Advancement program, into the regular meeting framework, and said the FDA will deliver the final recommendations to Congress by the January 2027 deadline.
FDA pushes back on claims of rising first-cycle rejections: 💊 CDER issued a report on September 16 with a long-term analysis of first-cycle complete response rates for new drug applications and biologics license applications. The FDA said outside analyses suggesting an increase in complete responses rely on public data that may not capture all applications, so it used its internal Document Archiving Reporting and Regulatory Tracking System instead. The report found that first-cycle complete response rates fell from 47% for the fiscal 2008 receipt cohort to about 27% for fiscal 2024, averaging 33.7% across the period. It described a rise from fiscal 2018 to 2020 as a “transient uptick” and closed with a list of agency activities, such as guidance and webinars, that “may reduce the likelihood of complete responses.”
Draft strategy on interchangeable biosimilars: 💊 The FDA announced on September 17 that it published a draft strategy document based on a September 2025 public hearing on developing interchangeable biosimilar products. The document outlines “specific actions FDA will take to facilitate interchangeable biosimilar product development.” It is meant to support a final strategy document that will guide FDA actions under the next Biosimilar User Fee Act.
BsUFA commitment letter released: 💊 The FDA released the draft commitment letter for the next Biosimilar User Fee Act on September 24 and scheduled an October 26 public meeting to discuss it. The next BsUFA program would take effect October 1, 2027, if Congress reauthorizes it. Proposed changes include new supplement categories with four- and six-month review timelines, a provisional approval process similar to the one for generic drugs, and a review extension that would let the FDA address “resolvable issues” late in review that might otherwise lead to a complete response. The letter would also fold the Biosimilar Initial Advisory Meeting into Type 2b meetings, add a “risk-based lifecycle approach” to manufacturing facility deficiencies, create new meetings to resolve facility-related approvability issues, and sunset the BsUFA Regulatory Science Pilot Program.
Gene therapy potency guidance under White House review: 💊 The White House Office of Information and Regulatory Affairs is reviewing an FDA guidance on potency assurance for cell and gene therapy products, according to an administrative record. The document appears to be a final version of draft guidance the FDA issued in December 2023, which drew significant feedback and some concerns from industry. CBER had listed it on its guidance agenda for this year. Its release would follow a separate draft guidance on potency assessments for active immunotherapy products.
Final guidance on buffy coat blood collection systems: 💊💉 The FDA finalized a guidance document on September 16 for developers of blood collection, processing, and storage systems used to manufacture blood components for transfusion. The guidance applies to systems that use the “buffy coat method,” which separates collected blood by spinning it. It details the information the FDA will ask sponsors for to support a regulatory filing. It also encourages companies moving away from DEHP-based collection systems, a transition the FDA supports, to contact the agency for help.
FDA replaces animal testing references in its regulations: 💊 The FDA issued a direct-to-final rule that replaces references to animal testing with the term “nonclinical tests” in nearly 40 places in its regulations. The rule carries out changes Congress made in late 2022, which defined nonclinical tests to include in vitro, in silico, in chemico, and nonhuman in vivo methods. The changes take effect February 4, and the FDA also published a companion proposed rule, with comments due December 7, in case it receives a significant adverse comment. Alongside the rule, the FDA launched a database of 25 case examples of review documents involving new approach methodologies, and Acting Commissioner Kyle Diamantas said the goal “is not to replace one rigid approach with another.” HHS described the rule as part of a wider set of actions that includes new NIH funding opportunities and smaller animal labs at NIH and CDC.