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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
Simple Reform restructuring takes effect: The FDA’s Simple Reform restructuring formally took effect on October 1, the first day of fiscal 2027. Most of the changes fall in shared services, such as the Office of Operations and a new enterprise technology office, while the product centers saw more targeted changes. Those include a new Office of Innovation and Clinical Trial Modernization at CDER with one division for real-world evidence and another for artificial intelligence. Marie Bradley, a longtime CDER real-world evidence policy leader, will lead the RWE division, according to her LinkedIn announcement. Leaders for the new office itself and its AI division have not yet been announced.
Two new FDA offices still lack permanent leaders: The FDA is still recruiting directors for two offices created under Simple Reform, the Office of Health Advancement and the Office of National Health Security. The Office of Health Advancement takes over many functions of the former Office of the Chief Medical Officer, including the offices of Clinical Policy, Orphan Products Development, Combination Products, Women’s Health, Minority Health, and Pediatric Therapeutics. The Office of National Health Security, which sits in the Office of the Commissioner, will oversee public health preparedness and supply chain resiliency staff. An FDA spokesperson said Acting Chief Information Officer Sanjay Sahoo is also serving as acting director of the new Office of Mission Information Technology Services, and that “organizational charts will be published as soon as possible.” The national health security vacancy comes as U.S. officials monitor reports of a pneumonic plague case in Russia, though there is no indication of wider spread.
New acting director for the Office of Generic Drugs: 💊 Darby Kozak is now acting director of the FDA’s Office of Generic Drugs, the FDA confirmed. Kozak was previously the office’s deputy director. Former Director Iilun Murphy stepped down to take an associate director position overseeing regulatory science, a move first reported by the Pink Sheet.
HHS acting general counsel departs: Robert Foster, HHS’s acting general counsel, has left the department, Endpoints News reported. Foster joined HHS in January 2025 and briefly served as acting chief counsel at the FDA. His LinkedIn page now lists him as the department’s former acting general counsel. HHS announced a reorganization of its Office of General Counsel in September that appears to eliminate the chief counsel for food, research, and drugs position Foster held from November 2025 to May 2026.
FDA workforce still down for the year: Updated Office of Personnel Management data show the FDA has lost 744 net employees in 2026, with figures current through August. That is a large improvement from 2025, when the agency lost 3,880 employees to layoffs. Even so, ongoing retirements and departures appear to have offset the FDA’s renewed hiring.
Klomp sets a five-year development goal: 💊 HHS Chief Counselor Chris Klomp said at The Wall Street Journal’s Future of Health Summit on October 7 that the U.S. should aim to cut the average time from concept to commercialization for new molecules from 15 years to five. He said that goal should be met “without a single ounce of compromise on safety and efficacy.” Klomp argued that when trials move overseas, “our best scientific minds sometimes follow,” which weakens the academic medical centers that would otherwise run those studies. He pointed to HHS’s Operation TrialBlazer, which is designed to keep trials in the U.S., and to a new ARPA-H initiative.
ARPA-H launches a clinical trial infrastructure push: 💊 The Advanced Research Projects Agency for Health, working with HHS, launched an initiative on September 30 to build technical infrastructure for continuous, adaptive clinical trials. The program, called SURPASS, will fund teams over five years that propose a phase-less platform trial in a single disease area, with goals that include simulation-based design environments and AI-enabled operational systems, according to the solicitation notice. ARPA-H is also launching projects on AI for trial site activation, national data-sharing infrastructure, and patient-contributed real-world data, all tied to HHS’s Operation TrialBlazer. The FDA launched a related AI-Enabled Optimization of Early-Phase Clinical Trials pilot in April, which appears not to have advanced since comments closed in late June.
FDA General
FDA lays out a Transparency Roadmap: 💊 The FDA published a blog post on October 2 by Lowell Zeta, deputy commissioner for strategic initiatives and special counsel, describing a new Transparency Roadmap that could change long-standing practices for disclosing applications and clinical data. Zeta wrote that the FDA will encourage sponsors “to make public the existence of an Investigational New Drug Application (IND) upon filing,” though the agency estimates 96% of novel drug or biologic filings are already publicly known. The FDA also plans more post-approval data disclosures, with redactions for confidential commercial and trade secret information, including publication of Clinical Study Reports for approved applications, alignment with EMA data transparency practices where feasible, and a pilot of expanded clinical dataset transparency. The EMA has published clinical data submitted to support marketing applications since 2016, though only through a specific portal and to qualified individuals, and it publishes specific data related to approvals, including clinical overviews, summaries, study reports, and protocols. The post does not mention Investigational Device Exemption applications.
Rare Disease Framework Initiative released: 💊 The FDA and HHS released the FDA’s Rare Disease Framework Initiative on October 14, calling for a “clear, consistent regulatory approach tailored to the specific challenges of rare disease drug development.” The stated goal is to make “fit-for-purpose evidentiary expectations” the norm for all rare disease applications. The document mainly lays out the case for change and the framework’s guiding principles, which include more predictable decision-making, embedding the patient voice in development and review, drawing on external expertise, and risk-based approaches to manufacturing and inspections. The FDA said it is considering revisions to existing regulations, possibly new ones, and a review of its guidance documents. OIRA cleared its release only days after receiving it. A Federal Register notice opens the white paper for comment, and according to the FDA and HHS announcement, the Reagan-Udall Foundation will host a public meeting on the initiative on October 28. The FDA and Reagan-Udall also scheduled an October 16 meeting on the patient voice in rare disease medical product development featuring several FDA rare disease leaders.
Peptide compounding policy reaches the White House: 💊 A document titled “Interim Access Policy for Compounding Using Certain Peptides” is now under review at the White House Office of Information and Regulatory Affairs. The document has not been released, but its title suggests a temporary enforcement discretion policy for compounding certain unapproved peptides, likely including some of the peptides the Pharmacy Compounding Advisory Committee reviewed at a July meeting. That committee recommended six of seven peptides for the list that permits compounding, overriding FDA staff concerns. The Washington Post reported on October 7 that HHS and the White House were planning to allow the temporary sale of some previously restricted peptides while officials write new regulations, and The Atlantic previously reported that Heidi Overton has worked on peptide policy in her role on the Domestic Policy Council. It is not yet clear whether the policy would cover outsourcing facilities.
FDA shares early thinking on ibogaine trials: 💊 The FDA published a request for information on October 6 sharing its “preliminary thinking” that early-stage ibogaine trials should test a single dose in an “intensively monitored” inpatient setting. The RFI suggests adults with opioid use disorder or post-traumatic stress disorder as possible study populations and asks 18 questions on trial design, safety, and oversight, given ibogaine’s known risks such as QTc prolongation. In a Washington Examiner op-ed the same day, Acting Commissioner Kyle Diamantas and CDER Director Mike Davis wrote that “simply opening the floodgates without proper guidelines would be dangerous and irresponsible.” The input could support new guidance building on the psychedelics guidance the FDA finalized in July. In April, President Trump directed HHS to support research on psychedelic treatments, including ibogaine. Comments are due November 20.
Clinical trial enrollment action plan guidance under review: 💊💉 A new FDA guidance titled “Clinical Trial Enrollment Action Plans to Improve Representation of the U.S. Intended Use Population in Clinical Studies” arrived at the White House for review on October 6. The title closely resembles the FDA’s existing guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” In a recent FDA Voices post, FDA center leaders Mike Davis, Karim Mikhail, and Michelle Tarver wrote that “trials that fail to enroll American patients can be less easily generalized to the population the products are intended to treat.”
OTC monograph forecast looks like last year’s: 💊 The FDA released its annual forecast of over-the-counter drug monograph changes on September 30, listing updates planned for four monographs in fiscal 2027. For the cold and cough monograph, the FDA plans to address codeine’s status as a cough medicine ingredient, propose a warning for propylhexedrine products about the risk of abuse and misuse, and reassess the “risks and benefits of cough-cold drug products in children under age 6 years.” The internal analgesic monograph would add updated pregnancy labeling for NSAIDs and weight- and age-based acetaminophen dosing for children under 12. The other two updates would address the status of benzocaine and phenol oral health products and of ipecac for poison treatment. An archived version of the page shows the forecast is nearly identical to last year’s.
Petition asks the FDA to restore its old homeopathy policy: 💊 A citizen petition from the Alliance for Natural Health-US and Meditrend, posted September 30, asks the FDA to revoke its current enforcement framework for homeopathic drugs and return to a 1988 compliance policy guide. The FDA’s December 2022 guidance treats homeopathic products as unapproved drugs and focuses enforcement on higher-risk products, such as those for serious conditions or vulnerable populations, or those with “significant quality issues.” The older CPG 400.400 essentially allowed any homeopathic product to be marketed if it was listed in the Homeopathic Pharmacopoeia of the United States and met basic requirements on labeling and the conditions it could treat. The petitioners argue the FDA violated the Administrative Procedure Act when it withdrew the old framework.
VRBPAC backs Southern Hemisphere flu strains: 💊 The FDA’s Vaccines and Related Biological Products Advisory Committee voted 9-0 on October 1 in favor of the proposed composition of egg-based trivalent flu vaccines for the 2027 Southern Hemisphere season. The recommendation covers two influenza A strains (H1N1 and H3N2) and one influenza B/Victoria lineage strain. The lineages match the FDA’s recommendations for the 2026-2027 U.S. season. Watch the discussion here.
Final guidance on biosimilar manufacturing changes: 💊 The FDA finalized its guidance on postapproval manufacturing changes for biosimilar products, revising a draft issued in July 2024. According to an FDA email bulletin, the final version aligns with the International Council for Harmonisation’s Q5E guidance, clarifies how applicants can use data from their original BLA to support a manufacturing change, and revises what information is needed to support a dosage form or strength not previously licensed. The FDA also reissued its biosimilar development Q&A document, withdrawing one question now covered by the new guidance. The guidance fulfills a commitment from the 2022 BsUFA reauthorization.
ANDA prioritization program turns one: 💊 October 3 marked one year since the FDA launched its program to prioritize review of abbreviated new drug applications that meet certain domestic testing and manufacturing criteria. “By prioritizing and expediting these ANDA reviews, this program rewards investment in U.S. drug manufacturing, research, and development and strengthens the domestic pharmaceutical supply chain,” the FDA wrote in a LinkedIn post. The program is one of several FDA efforts to encourage domestic drug manufacturing.
CBER updates its PDUFA payment procedures: 💊 CBER updated its standard operating procedures and policies document for processing Prescription Drug User Fee Act application payments. According to the change log, the update reflects user fees now being handled as a shared service. Payments now route through the Office of User Fees under the Division of User Fee Revenue Management, in line with the Simple Reform changes, instead of the Office of Regulatory Operations. CBER made similar changes earlier in October to an SOPP describing how it processes BLAs and NDAs.