RA/QA News Roll: Mid July 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
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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
Commissioner search narrows to three finalists: Reporting from STAT indicates the search for a permanent FDA commissioner is in its late stages with three main contenders, all of whom hold medical degrees: Heidi Overton, Jeffrey Vacirca, and Stephen Ferrara. Overton is deputy assistant to the president for domestic policy and previously led the Center for Healthy America at the America First Policy Institute. Vacirca is an oncologist and CEO of New York Cancer & Blood Specialists. Ferrara is principal deputy assistant secretary of defense for health affairs. The list has reportedly been sent to the White House for a final review and decision.
A larger leadership restructuring may be coming: The Pink Sheet reported that HHS is considering adding a new layer of management at the FDA, potentially reviving a senior position similar to the former deputy commissioner for medical products and tobacco. That role was created in 2011 and abolished in the 2018 reorganization, which had the medical product center directors report directly to the commissioner. The position under consideration would return to the earlier structure, placing a senior leader between the commissioner and the center directors. Separately, recent reporting indicated the administration intends to announce new leaders for both CBER and CDER alongside its commissioner nominee.
Diamantas sets four public health priorities: In an FDA Voices post, Acting Commissioner Kyle Diamantas outlined four priority pillars for the agency. The pillars align with the current agenda and include a few new details.
Differences in CBER leadership: Acting CBER Director Karim Mikhail is taking a different approach than his predecessor, five anonymous agency officials told STAT. Mikhail is largely staying out of the center’s review work, which his predecessor had at times closely involved himself in, and he participated with Diamantas in a roundtable with rare disease patient groups aimed at mending ties with a community frustrated by drug rejections. He is also reported to be focused on staff morale. It is not clear whether he will be named permanently, as the administration is expected to announce new CBER and CDER leaders alongside its commissioner nominee.
More leadership departures follow the spring turnover: 💊 Deputy Chief Medical Officer Mallika Mundkur will leave the agency, writing on LinkedIn that she plans to move into the world of innovation. She played a central role in several high-profile initiatives, including the CNPV program and the early-phase clinical trials pilot, and agency documents for those programs delegate key tasks to the deputy chief medical officer, so it is not clear who will take over her responsibilities. Acting Chief Information Officer Sridhar Mantha is also leaving, further thinning the FDA’s technology leadership after the earlier departure of the chief AI officer. Former chief medical officer for digital health Matthew Diamond left for Siemens Healthineers, and agency veteran Lisa Yanoff became CDER’s acting deputy director for clinical science.
FDA hiring shows small gains at CDER: 💊 The FDA gained 26 net employees at CDER but lost six net employees at CBER in the third fiscal quarter. Both centers shrank significantly last fiscal year and have each lost about 50 more employees on a net basis this year. CDER added more staff than it lost for the first time since the end of 2024. More on this here.
FDA General
Administration releases an ambitious FDA rulemaking agenda: On July 3, the administration released its 2026 Unified Agenda, listing a dozen new proposed rules for the FDA on topics including clinical trial reform, expediting Phase 1 trials, direct-to-consumer advertising, formalizing proactive disclosure of Complete Response Letters, animal testing citations, distributed and point-of-care manufacturing, supply chain transparency, e-labeling for medical devices, and updates to Part 11 on electronic records. The agenda also lists two new final rules and reinstates records previously removed, including biologics regulation modernization, adverse event records and reports, and a long-awaited final rule establishing Patient Medication Information labeling. (Target publication dates in the agenda are aspirational and nonbinding.)
Proposed rule on distributed manufacturing and foreign registration published: 💊💉 The FDA published a proposed rule that would clarify registration requirements in two areas: drug manufacturers implementing distributed manufacturing methods and foreign establishments whose products indirectly enter the U.S. drug supply. The foreign establishment provisions implement the PREVENT Pandemics Act, which directed the agency to clarify that registration and listing requirements apply regardless of whether further manufacturing steps occur after a product is imported. The rule also outlines a pathway for a distributed manufacturing establishment to register multiple physical locations as a single establishment. Comments are due in September.
FDA to launch a Quantitative Medicine Innovation Network: 💊 The FDA plans to establish a network bringing together academic institutions, industry sponsors, contract research organizations, regulators, and patient advocates to advance the science and regulatory application of quantitative medicine. An Innovation in Quantitative Medicine Summit, co-convened with the FDA on September 1, will inform the effort, which aligns with CDER’s Quantitative Medicine Center of Excellence launched in 2024. Note that the actual registration page is different; you can find it here. More on the CDER’s QM CoE program here.
CDER adds four guidances to its agenda: 💊 CDER updated its regulatory agenda with four new draft guidances: supplemental guidance on computer software assurance for AI-based systems in drug manufacturing and clinical research, a Q&A on unbranded biological products, advice on pharmacokinetic criteria to support alternative dosing of Fc-containing protein drugs, and recommendations for submitting postmarketing safety reports electronically. The additions bring CDER’s list of planned guidances to 85!
FDA finalizes psychedelic drug development guidance and plans a public hearing: 💊 The FDA finalized clinical guidance on psychedelic drug product development that it had drafted three years ago and announced a public hearing to gather input on the compounds’ therapeutic uses. HHS also issued a request for information on training and care delivery models ahead of future FDA approvals. The White House has separately cleared new guidance on clinical considerations for serotonin-2a agonists and related products, which the FDA can publish at any time.
Final guidance on OTC monograph meetings: 💊 The FDA finalized recommendations on requesting formal meetings to discuss OTC monograph development programs, updating 2022 draft advice to reflect commitments made during reauthorization of the OTC Monograph User Fee Act and comments on the draft.
FDA outlines a process for requesting data on OTC monographs: 💊 A Federal Register notice describes how the FDA will issue requests for data when preparing future actions on OTC drug monographs, such as initiating a proposed order to add a generally recognized as safe and effective condition. The agency will announce data requests on its OTC monograph portal and list planned requests on a nonbinding annual list.
Final guidance on generic topical steroid bioequivalence: 💊 The FDA finalized guidance for in vivo bioequivalence studies for generic topical dermatologic corticosteroids, replacing a 2022 draft. The document outlines a two-part approach that first establishes a pilot dose-response relationship using skin blanching as a surrogate measure, then uses those parameters in a pivotal study. The agency tied the release to its Drug Competition Action Plan.
eCTD standards updated: 💊 The FDA released its first 2026 update to the Electronic Common Technical Document v4.0 format standards, revising the regional package, technical conformance guide, and transmission specifications, and adding regional forward compatibility XML samples.
Citizen petition seeks an advisory committee on anticholinergic drugs: 💊 A retired FDA medical officer filed a citizen petition asking the agency to convene an advisory committee on the dementia risk of prolonged anticholinergic exposure in middle-aged and older adults, and to consider whether certain OTC products such as diphenhydramine and chlorpheniramine should be made prescription only or packaged with fewer doses and warnings.
Updated pediatric research metrics: 💊 The FDA updated top-line metrics on reviews of pediatric studies. Since 2012, the agency has reviewed 101 products under the Best Pharmaceuticals for Children Act, 584 under the Pediatric Research Equity Act, and 83 under both, adding 57 products since the February update.
CBER plans a fall roundtable on blood product supply: 💊 CBER plans to hold a roundtable in the fall on gaps in the supply chain for blood collection and transfusion products, following a May webinar on how it reviews blood and source plasma applications.
FDA updates blood and tissue screening for the Ebola outbreak: 💊 In response to the Ebola outbreak in the Democratic Republic of the Congo and Uganda, the FDA updated its 2014 guidance for blood establishments on donor eligibility, deferral, and product management, asking establishments to screen donors for residency or travel to the affected countries. The agency confirmed establishments should incorporate the revised screening by July 27, and later sent an additional alert to human cell and tissue product establishments flagging screening considerations for donors.
TAP program opens to all therapeutic areas: 💉 As of July 1, the Total Product Lifecycle Advisory Program opened to all therapeutic areas, so any qualifying device, including those with breakthrough or Safer Technologies Program designation, can apply to participate. TAP participation is also part of the eligibility criteria for the joint FDA and CMS RAPID coverage pathway.
CDRH third-party 510(k) program metrics posted: 💉 CDRH published a second-quarter 2026 performance report on its third-party 510(k) review program. Seven accredited third parties have not completed five submissions this year, so the agency did not provide comprehensive information about them, while two organizations that reached the volume threshold received individualized reports.