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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
Forshee returns to lead CBER’s biostatistics office: 💊 Richard Forshee is now director of CBER’s Office of Biostatistics and Pharmacovigilance, he confirmed in a LinkedIn post. Forshee was previously the office’s deputy director but left in October 2025 to become associate director of benefit-risk assessment in CDER’s Office of Surveillance and Epidemiology. STAT News previously reported that former CBER Director Vinay Prasad was active in motivating Forshee out of the office.
CDRH reports high staff attrition: 💉 CDRH Director Michelle Tarver estimated the center’s attrition rate at 22% to 25% during a CDRH town hall at AdvaMed’s MedTech Conference in Boston on October 21. Tarver said the center has met its hiring goals under the user fee agreement, but losses have reached up to 30% of clinical reviewers in some areas, and digital health and AI staff were also hit hard. At the same conference, CDRH Deputy Director for Regulatory Policy Angie Krueger said the center’s internal AI tools are not making total product lifecycle decisions. “Our staff are doing that,” she said, adding that the tools are used “to summarize information, help prepare briefings, put presentations together, help us connect disconnected information.”
OPM finalizes rules on promotions and senior staff appraisals: The Office of Personnel Management finalized a rule that removes a requirement that General Schedule employees hold a position for at least 52 weeks before they can advance. OPM said the change lets employees who otherwise meet qualification standards get promotions. A second rule changes how senior-level and scientific professionals are assessed so the process “aligns more closely with Senior Executive Service (SES) performance appraisal regulations.” Both rules were scheduled for publication on October 19, with the General Schedule rule taking effect 90 days later and the senior-level rule 30 days later.
Executive order creates an NIH women’s health division: President Trump signed an executive order on October 19 directing HHS to establish a new women’s health division within the National Institutes of Health. The order also creates a Women’s Health Task Force led by HHS Secretary Robert F. Kennedy Jr. and White House Chief of Staff Susie Wiles, with members who include the heads of the FDA, CDC, NIH, CMS, and ARPA-H. The new NIH division will advance research on conditions affecting “all phases of life,” improve understanding of sex-specific health outcomes, and increase “inclusion of women and girls in clinical trials.” The order revokes a 2024 order from President Joe Biden on women’s health research and an earlier presidential memo that set up a White House initiative on women’s health.
FDA General
HHS issues its interim peptide compounding policy: 💊 HHS issued an interim policy on October 28 saying it will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound with six specific peptides. The six peptide bulk drug substances are BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500, which an FDA advisory committee recommended adding to the compounding list in July over FDA staff objections. HHS based the policy on “significant interest” and a lack of “approved products.” Conditions include that substances comply with NF or USP monographs where they exist, be components of approved drugs, or match the chemical structures in the HHS appendix, and come from an FDA-registered facility that complies with manufacturing rules. Compounders must report serious adverse events to MedWatch, and products must be labeled not for resale and contain a single active ingredient. The policy is intended to remain in effect while the FDA develops a permanent list through rulemaking.
State boards will shape the peptide policy’s reach: 💊 The peptide policy’s reach will depend heavily on state boards of pharmacy, which are the main regulators of the 503A pharmacies it covers, POLITICO reported. The FDA primarily regulates 503B outsourcing facilities, which can ship across state lines. Given FDA staff’s concerns about the peptides, sources told POLITICO that at least some states will likely prohibit compounding them.
Petition asks the FDA to block peptide compounding: 💊 The Partnership for Safe Medicines filed a citizen petition urging the FDA to “block compounding of unapproved peptides and to disregard the advisory committee vote that recommended allowing them.” The petition argues the committee was constituted in violation of the Federal Advisory Committee Act and the Ethics in Government Act. Claims raised in the petition could become the basis for future litigation against the policy. Before HHS released the policy, five groups scheduled meetings with White House reviewers on it: the Center for Science in the Public Interest, the Alliance for Pharmacy Compounding, Hims & Hers Health, the American Academy of Peptide Medicine, and Medivant Healthcare.
Surrogate endpoint tables drop several vaccine entries: 💊 The FDA updated its reference tables of surrogate endpoints “that were the basis of drug approval or licensure” on October 29, the first update since late April. The update adds a few surrogates used in recent approvals but appears to remove several related to immunization. The adult non-oncology table no longer lists full-length S-binding immunoglobulin G for Covid-19, anti-hepatitis A antigen antibody for hepatitis A vaccines, or neutralizing antibodies to RSV A and B for RSV-related lower respiratory tract disease. Several surrogates were also removed from the pediatric table, and the update does not appear to include some recently used surrogates, such as minimal residual disease in multiple myeloma and reduction in cornstarch reliance in glycogen storage disease Type 1a.
FDA leaders promise predictability in rare disease framework: 💊 Senior FDA leaders said at an October 28 public meeting with the Reagan-Udall Foundation that the agency’s Rare Disease Framework Initiative will rebuild how it reviews drugs for rare conditions. “The vision here is for this to be a true quantum leap, not another program, not another step, but an actual tool built from scratch all the way bottom up with every stakeholder,” said CBER Director Karim Mikhail. “We want to maximize predictability,” said CDER Director Mike Davis, who added that the work will be “very focused on reaching deliverables” and not “working groups with 50 people in it that go on for years and years.”
FDA launches a neuroscience initiative starting with Alzheimer’s: 💊💉 The FDA launched the Neuroscience Advancement and Innovation Nexus on October 22 to coordinate regulatory science for medical products that treat diseases of the brain and nervous system. NAIN will draw on expertise across the medical product centers and cover neurologic and psychiatric disorders, substance use disorders, and pain, among other areas. Its first project is the Alzheimer’s Prevention Accelerator, which will focus on “trial populations, stage-appropriate endpoints, and evidentiary approaches” for showing prevention or delay of cognitive decline. Both were announced alongside an HHS update to the National Plan to Address Alzheimer’s Disease and Related Dementias. At a related event, Acting Commissioner Kyle Diamantas pointed to recent authorizations of blood-based Alzheimer’s tests and said the agency’s “responsibility is to ensure regulatory science keeps pace with these advances.” (Leqembi is currently being tested in a large Phase 3 study of asymptomatic adults with intermediate or elevated brain amyloid.)
Rare disease ARC program issues its annual report: 💊 The FDA published a new annual report for its Accelerating Rare disease Cures (ARC) program on October 22. Launched in May 2022, the program aims to “provide strategic overview and coordination of CDER’s rare disease activities.” The report came out earlier than last year’s edition, which was released in early December, and it highlights the program’s 2025-2030 Strategic Plan and an expanded library of rare disease case studies under the LEADER 3D initiative. It does not address ARC’s role in the agency-wide Rare Disease Framework Initiative, which held its public meeting on October 28.
Workshop coming up on ovarian cancer maintenance therapy: 💊 The FDA scheduled a virtual workshop for the afternoons of November 12 and November 19 on maintenance treatment for ovarian cancer. The meeting will focus on weighing benefit against toxicity, noting that newer therapies such as antibody-drug conjugates can carry substantial toxicity. Discussion will cover contextual interpretation of efficacy endpoints, dose optimization, and biomarker strategies.
Nonprescription drug pilot will launch this year: 💊 The FDA confirmed in a newly published webpage that a pilot program for nonprescription drug developers will launch this calendar year. Karen Murry, head of the Office of Nonprescription Drugs, first described the pilot at a public meeting in April, and the FDA had shared no details since. The webpage says the pilot will “provide a structured opportunity” for discussions between sponsors and the FDA early in a nonprescription development program. It also confirms the FDA intends to issue new draft guidance on nonprescription drug development.
Final technical guidance on driving studies: 💊 The FDA issued a new technical guidance recommending how trial sponsors should collect and submit data on participants’ ability to drive. The FDA has previously issued public warnings about drugs that impair driving. The guidance highlights measures such as the Standard Deviation of Lateral Position, lane exceedances or drifts, response time, and number of collisions, which are often assessed in computer simulations. It is meant to be read alongside the FDA’s 2017 clinical guidance on the same topic.
RFI on patient-level RWE data heads to the White House: 💊 The White House Office of Information and Regulatory Affairs received an FDA request for information on October 15 on “patient-level data for drugs and biological products submissions containing real-world data and real-world evidence.” Former Commissioner Martin Makary announced in December that the FDA would “accept RWE without requiring that identifiable individual patient data collected from real-world data sources always be submitted in a marketing submission.” At the time, the agency released a guidance document that applied only to medical devices and said it would consider updating its drug and biologic guidance. The RFI could also be one of the first chances to hear from CDER’s new Division of Real-World Evidence Analytics, led by Acting Director Marie Bradley.
Container closure guidance draws dozens of comments: 💊💉 Dozens of companies and trade groups have commented on the FDA’s first overarching draft guidance on container closure systems. The August draft guidance covers the packaging components that contain and protect a drug or biologic’s dosage form, including drug delivery system devices, and sets out a risk-based framework for protection performance, chemical leaching, manufacturing impacts, and storage and handling. PhRMA said the guidance is not aligned with certain international harmonization standards, is overly broad, and is not appropriately tailored to combination products. The Consumer Healthcare Products Association and the U.S. Pharmacopeia also commented.
Revised draft guidance renames EDDOs as EDDCs: 💊💉 The FDA issued a revised draft guidance on October 29 that renames “essential drug delivery outputs” as “essential drug delivery performance characteristics,” or EDDCs, for devices that deliver drugs and biological products. The 2024 draft was the first formal guidance on the topic, which historically used the term “essential performance requirements.” The revision updates its citations to the Quality Management System Regulation, which replaced the Quality System Regulation in February, and heavily revises testing expectations for drug-delivery performance, while Appendix C’s example characteristics by product type is largely unchanged. Comments are due January 28. Combination Products Office Director James Bertram and other FDA leaders will attend November’s Combination Products Summit.
Combination product designation requests are rising: 💊💉 A Federal Register notice published October 23 on combination product information collection says the FDA has seen “an increase in the number of submissions we received over the last few years.” For 2027, the agency expects 146 requests for designation and pre-RFDs, 14 more than in previous years, and three Combination Product Agreement Meeting requests, unchanged. The Office of Combination Products now sits under the Office of Health Advancement after Simple Reform, but its organization and function are otherwise the same.
Final guidance on prescription drug use-related software: 💊💉 The FDA released final guidance on October 20 on prescription drug use-related software, including apps used with a prescription drug. The FDA considers PDURS an extension of a drug’s labeling rather than a medical device. The guidance covers how PDURS will be subject to FDA labeling review, how companies should reference it on drug labels, and what they need to submit to the agency.
FDA tells the FCC its RF exposure views may change: 💉 The FDA sent an October 19 letter to the Federal Communications Commission saying the health agencies are studying radiofrequency and electromagnetic field exposure and that their research might lead to updated recommendations. In 2019, the FDA told the FCC there was not compelling evidence that RF/EMF exposure posed health concerns, and the FCC’s resulting report said “no evidence has moved our sister health and safety agencies to issue substantive policy recommendations for strengthening RF exposure regulation.”
CDRH counts 2,100 devices with rare disease indications: 💉 CDRH Director Michelle Tarver said at an October 16 meeting on the patient voice in rare disease product development that about 2,100 devices have on-label rare disease indications. Many are diagnostic tests, which Tarver said can help sponsors use tests the FDA has already evaluated “as opposed to starting from scratch.” The information is part of the center’s Rare Disease Impact Initiative, launched in September. Tarver said sponsors should expect CDRH reviewers to “take a more involved and engaged role in suggesting” rare disease uses, and that about half or more of the center’s submissions now include patient-reported outcome measures.
CDRH posts hypothetical PCCP examples: 💉 CDRH updated its predetermined change control plan webpage on October 20 with two hypothetical examples of PCCP use cases. The examples cover a hospital-localized sepsis alert system and continuously learning cardiac arrhythmia detection software. Digital Health Center of Excellence Director Rick Abramson said they were developed “based on feedback from AdvaMed” and that the center is “very much waiting for feedback from the community” on whether to produce more.
Three more device types codified: 💉 CDRH issued a final classification order on October 29 for spinal imaging systems for neuraxial procedures, one of three orders it released that day for device types first established through De Novo requests in early 2024. The other two cover digital assessment tools: OTC risk assessment software for sleep apnea and software-aided adjunctive diagnostics for “lesions suspicious for skin cancer.” All three are Class II, and the special controls for the algorithm-based products include labeling on device performance across subgroups and on interpreting outputs.