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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.
FDA Leadership and Administration
FDA names permanent center directors and a first-ever AI deputy: The FDA promoted three existing officials, making Mike Davis the permanent director of the Center for Drug Evaluation and Research, Karim Mikhail the permanent director of the Center for Biologics Evaluation and Research, and Jared Seehafer the agency’s first deputy commissioner for technology and artificial intelligence. Davis and Mikhail had both been serving in an acting capacity. Seehafer, most recently a senior advisor, will be the senior leader for technology, software, and AI and will set agency-wide strategy in those areas, though the full remit is expected to be detailed after a new commissioner is confirmed. All three have maintained lower public profiles than their predecessors, and all three have operational rather than purely academic backgrounds: Seehafer and Mikhail were company founders and CEOs before joining the agency, and Davis has extensive experience leading within CDER. Mikhail and Seehafer hold scientific master’s degrees rather than the doctorates most FDA medical leaders have traditionally held.
Overton’s nomination formally transmitted to the Senate: The White House sent Heidi Overton’s nomination for FDA commissioner to the Senate on September 14, clearing the way for confirmation hearings to be scheduled. The hearings are likely to involve the Health, Education, Labor and Pensions Committee and possibly the Senate Finance Committee. Overton currently serves on the White House Domestic Policy Council, which makes it likely she was aware of and signed off on the recent center director promotions, since those officials would be among her closest colleagues if she leads the agency.
CBER fills out its leadership roster: 💊 CBER updated its leadership page to show acting office directors and an acting deputy director, including John Scott as acting director of the Office of Biostatistics and Pharmacovigilance and Vincent Amatrudo as acting director of the Office of Compliance and Biologics Quality. Sudhakar Agnihothram is acting deputy director of the Office of Vaccines Research and Review, Megha Kaushal is acting deputy director of the Office of Therapeutic Products, Steven Oh is acting director of OTP’s Office of Cellular Therapy and Human Tissue, and Steven Fleischer is acting director of OTP’s Office of Pharmacology/Toxicology. A seat is still unfilled: Mikhail is still listed as acting director of OTP, the cell and gene therapy super office, following Vijay Kumar’s departure earlier this year. Several of the changes appear to predate the webpage update, with two of the named officials listing earlier start dates on their own profiles.
New CBER director outlines how he weighs access against evidence: 💊 In his first public post since becoming permanent CBER director, Karim Mikhail signaled that he will weigh the cost of patients going without a therapy more heavily when deciding whether to approve it. Writing on LinkedIn, Mikhail said the scientific record tells you what a therapy does but cannot tell you what waiting for it costs, and described learning that from families whose disease has no approved treatment, for whom a review timeline is not a metric but time they may not have. He added that he wants frameworks fit for the science in front of the agency rather than the science behind it, with sponsor and regulator functioning as two disciplines accountable to the same person rather than two parties negotiating across a table.
Davis signals a return to regular order at CDER: 💊 In an interview with BioCentury, new CDER Director Mike Davis described his intent to listen more to center review staff and convene more advisory committee meetings. The publication characterized the theme as a return to regular order, a notable contrast with the prior leadership’s approach to both staff input and advisory committees.
FDA and SEC sign an information-sharing agreement: The FDA and the Securities and Exchange Commission signed a memorandum of understanding intended to provide a framework for enhanced cooperation in their regulatory and enforcement responsibilities. The MOU covers information-sharing protocols, including non-public information, with much of the document describing how each agency will safeguard what it receives. Publicly traded companies are typically required to disclose material information about their FDA interactions, including complete response letters, approvals, application filings and acceptances, and compliance actions. The agreement arrives as betting platforms drive increased interest in clinical trial readouts.
HHS opens the EUA pathway for military operations: 💊 HHS issued an emergency use authorization declaration covering drugs identified and supported by the Department of Defense as addressing an unmet military operations-related medical need. EUA declarations typically respond to a defined public health emergency such as COVID-19, mpox, Zika, or Ebola, with specific indications attached. This one names no specific public health concern, instead opening the pathway to drugs for managing moderate to severe acute pain in casualties caused by biological, chemical, radiological, or nuclear agents, or by agents of military combat including firearms, projectiles, and explosive devices, where there is an imminently life-threatening and specific risk to U.S. forces. No product list or therapeutic areas have been identified. An existing MOU between the FDA and DOD already provides for enhanced collaboration while preserving the FDA’s authority over medical product authorizations.
FDA General
Expedited IND pilot opens for applications: 💊 The FDA began accepting applications on September 15 for its pilot program to expedite Investigational New Drug applications, announcing the program’s final design at the same time. The agency expects to select between eight and 10 applications, submitted jointly by sponsors and research institutions planning to work together. Applications close October 30, with participants chosen by December 18. The FDA wants to test whether collaboration between sponsors and research institutions improves IND submission quality, and it plans to review submissions on a rolling basis through the program. Mikhail said on a press call that what the agency learns from the first cohort can inform the future of early-stage drug development in the U.S., while Davis noted that future approaches could include a formal accreditation model recognizing qualified research institutions. For the pilot itself, the FDA retains full regulatory authority and oversight.
New draft guidance on hepatic impairment pharmacokinetics: 💊 The FDA issued a new draft guidance on how drug developers should assess pharmacokinetics in patients with impaired liver function. The question matters because many drugs are metabolized through the liver, and reduced hepatic function can cut efficacy or raise safety concerns. The document covers how sponsors should decide whether to run dedicated PK studies and, if so, how to design them and analyze the results. It appears to replace a 2023 guidance that the agency withdrew the same day.
Prior knowledge guidance draws calls to broaden its scope: 💊 The comment period closed on the FDA’s June draft guidance describing how sponsors can leverage prior knowledge to develop human genome-editing products. Many stakeholders urged the agency to extend the recommendations beyond genome editing products, and several pushed for clarity on how the guidance connects to related concepts including the plausible mechanism framework and platform technology designation. The document could help sponsors repurpose existing manufacturing, nonclinical, and clinical data, reducing what they need to collect anew when testing novel products.
Temporary compounding flexibilities for neonatal parenteral nutrition: 💊 The FDA published guidance effective immediately that allows compounders certain flexibilities to make starter parenteral nutrition drug products for neonates, citing potential serious supply disruptions. The flexibilities run 180 days, through March 8. The agency has issued similar stopgaps in recent years, though this one arrives amid heightened attention to this patient population.
FDA lays out its thinking on psychedelic drug development: 💊 New CDER Director Mike Davis and several other agency officials wrote that the FDA is open to reviewing and approving psychedelic therapy for mental health disorders, though how such treatments fit existing regulatory frameworks is still evolving. The article, coauthored with Division of Psychiatry Director Tiffany Farchione and Division of Neuroscience Director Teresa Buracchio, expands on guidance the agency finalized in July addressing the functional unblinding problem that complicates research in this field. The authors wrote that the FDA is open to comparators other than inert placebos, including active comparators or low doses of the compound under study, but may still expect a placebo-controlled trial. They acknowledged that psychedelics can be dosed intermittently and described the agency as receptive to approval based on efficacy over a relatively short period, followed by longer-term assessment of the need for and safety of additional doses. They also noted the agency may require a Risk Evaluation and Mitigation Strategy.
Sunscreen monograph finally loses two ingredients: 💊 The FDA amended its sunscreen ingredient monograph to remove aminobenzoic acid and trolamine salicylate, which it had previously determined were no longer considered safe or effective.
Priority review voucher redemption fee set for fiscal 2027: 💊 The FDA set the fee for redeeming a priority review voucher in fiscal 2027 at $1,798,596. Unlike the Commissioner’s National Priority Voucher program, these vouchers are not free to redeem. Companies must pay both the standard filing fee and an additional fee to cover the extra staff work required to expedite a review. The amount is set by a formula estimating the cost of a priority review relative to a standard one.
Botanical drug development draws a request for input: 💊 The FDA said it wants to accelerate development of botanical drug products, including algae, beyond the scope of its 2016 guidance, and posted a Federal Register notice on September 3 seeking stakeholder input. Botanical drugs, made by growing plants or fungi rather than through chemical synthesis, raise distinct regulatory questions around dose standardization, plant purity, and the effects of growth methods on safety, including pesticide use and heavy metal uptake from soil. The notice asks about development challenges and how the agency can help through guidance or other support. A workshop with the European Medicines Agency is in the works.
Survey planned on pregnancy exposure registry enrollment: 💊 The FDA announced a need for data on pregnancy exposure registries and proposed a new survey of health care providers to identify perceived barriers to patient enrollment. The notice indicates the agency believes many registries fail to enroll adequately, and that it is weighing ways to encourage enrollment through providers based on what the survey finds.
Oncology outcomes workshop scheduled for October: 💊 The Oncology Center of Excellence will hold its annual workshop on clinical outcome assessments in cancer trials on October 15. Two panels will examine whether researchers are measuring the outcomes that matter most to patients, including how therapies such as CAR-T create new assessment challenges and whether technologies such as AI-assisted monitoring can be designed to gather more meaningful data. An agenda and speaker list are still to come.
Rare disease statistics workshop opens its docket: 💊💉 A Federal Register notice published September 15 opened a docket for the next event in the FDA’s Rare disease Innovation, Science, and Exploration workshop series, titled “RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations.” The hybrid event takes place September 29, with draft sessions covering randomization and control arms, navigating trade-offs, and improving efficiency, plus a case study on statistical considerations for brain-computer interface devices in amyotrophic lateral sclerosis. The agency developed two pre-read documents, one for drugs and biologics and one for devices, which had not yet been posted at the time of the notice. Comments run through November 13.
Patient voice meeting planned for rare disease development: 💊💉 The FDA will host a meeting October 16 with the Reagan-Udall Foundation to explore the patient voice in rare disease medical product development across biologics, drugs, and devices. The session will also look at additional opportunities for patients to engage in the product development process.
Compounding quality conference opens its call for proposals: 💊 The FDA opened a call for proposals for its Compounding Quality Center of Excellence Conference, which it will cohost with the International Society for Pharmaceutical Engineering. The conference arrives after a year in which the agency significantly stepped up oversight of certain compounding activities, particularly those involving GLP-1 and other weight loss drugs.
Pharmacogenetic associations table gets its first update in years: 💊 The FDA updated its table of known pharmacogenetic associations, genetic markers that affect drug safety or efficacy, for the first time in nearly four years. The update adds more than 20 drug products, including gentamicin, bupropion, and dextromethorphan.
Two final dental device guidances published: 💉 The FDA published final guidance documents covering premarket notification submissions for dental composite resin devices and dental curing lights. Both finalize 2024 drafts and replace final guidances from 2005 and 2006. The composite resin guidance updates the specification of radiant power output at the tip and removes resin depth-of-cure measurements.
Eight device types moved to Class II: 💉 The FDA announced it is classifying eight device types as Class II after finding them moderate-risk despite being innovative, which lets them serve as predicates for future premarket notifications. The list covers whole-room microbial reduction devices, vaginal hydrogel packing systems, implanted tibial electrical urinary continence devices, cooperative powered surgical assist devices for ENT surgery, anti-tumor necrosis factor alpha monoclonal antibody test systems for inflammatory bowel disease, extravascular support for arteriovenous fistulas, and two esophageal protection devices for cardiac ablation procedures, one temperature-regulating and one mechanical.
Cardiovascular machine learning software classified as Class II: 💉 The FDA classified cardiovascular machine learning-based notification software as Class II, allowing future submissions to use the 510(k) pathway. The first such device cleared by the agency was authorized in August 2023.
Biocompatibility town hall covers the new ISO standard: 💉 The FDA’s first biocompatibility town hall on September 9 focused on updates to the international biocompatibility standard ISO 10993-1:2025 and the continued relevance of the agency’s guidance on using it. CDRH’s Shuliang Li said the major change in the sixth edition is realignment with ISO 14971, the risk management standard the FDA recognizes in full. The revisions refine device categorization to account for exposure duration including intermittent contact, and remove the externally communicating device category in favor of categorizing by tissue type and whether skin or mucosa is intact, breached, or compromised. The standard carries a three-year transition, so the agency will accept declarations to the 2018 version until July 1, 2029. Li added that the FDA is not raising its expectations for biological evaluations.
Device lists for AI, VR, and sensors refreshed: 💉 The FDA released updated webpages listing approved or cleared devices that use artificial intelligence, augmented and virtual reality, and digital health technology sensors. The lists let developers identify predicate devices to reference and get a clearer picture of the agency’s evidentiary expectations.
Emerging pathogen diagnostics guidance nears finalization: 💉 A guidance document addressing how sponsors can validate in vitro diagnostics intended to detect emerging pathogens during a declared public health emergency is advancing, according to a new White House notice. The guidance was released in draft form in January 2025. The agency’s aim appears to be better preparation for future emergencies by clarifying in advance what it expects from developers of tests for emerging pathogens.
CDRH publishes a regulatory reliance resource: 💉 CDRH posted a new Regulatory Reliance Portal, an educational webpage describing how the center oversees and regulates medical devices, intended as a resource for foreign regulatory authorities. Reliance differs from harmonization: rather than converging on a single common framework, one regulator gives significant weight to another’s decisions. The page offers information on establishing the FDA as a comparable regulator whose assessments other authorities can consider.
New regulatory science tool for respirator materials: 💉 CDRH published a new regulatory science tool for developing personal protective equipment materials, a Respirator Filtration Efficiency Calculator. The calculator helps developers assess respirator and mask textile materials by estimating particle filtration efficiencies against a reference, a surgical N95 respirator. Regulatory science tools do not carry the weight of qualified Medical Device Development Tools, but they give developers a way to demonstrate performance where standards and MDDTs do not yet exist.
