RA/QA News Roll: Mid March 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
White House considered replacing FDA chief operating officer — The Washington Post reports that Chris Klomp, the new HHS Chief Counselor, was briefly pitched by the White House to serve as the FDA’s chief operating officer before he declined the position. Administration officials had sought Klomp for management counsel to help stabilize operations at the FDA after several resignations and policy shifts, which puts additional context behind FDA Chief Operating Officer Barclay Butler’s recent decision to retire from public service.
HHS counselor influences vaccine policy timing — The Washington Post piece also reports that Chris Klomp was responsible for delaying a planned vaccine announcement out of concern it would create political headaches and overshadow other priorities. The report indicates that outgoing CBER Director Vinay Prasad was among officials under Klomp’s “broadened purview” who are set to exit HHS.
Prasad's departure creates a second leadership void at CBER 💊 — The FDA announced that CBER is seeking not only a replacement for departing Director Vinay Prasad but also an additional deputy director position. The agency spokesperson confirmed this hiring is for an additional deputy director to join CBER’s current deputy director, Katherine Szarama, as Prasad prepares to leave around the end of April.
Kennedy signals peptide compounding changes coming 💊 — HHS Secretary Robert F. Kennedy Jr. told Joe Rogan’s podcast that the FDA will likely reverse the majority of Biden administration restrictions on bulk compounding of 26 peptide products within weeks. Kennedy indicated the FDA plans to allow “about 14” types of peptides to be compounded, citing concerns about high consumer demand driving people to order from unregulated Chinese or Indian labs.
Anthropic AI restriction affects FDA’s Elsa tool — President Trump’s decision to prohibit Anthropic from doing government business impacts the FDA’s generative AI tool Elsa Enterprise, which leverages Claude’s “Sonnet” model. HHS disabled staff Claude accounts while the FDA implements “phased transition to remove Claude Sonnet from Elsa,” while ensuring “functionality and capabilities are uninterrupted.”
FDA General
Major adverse event monitoring system consolidation launched — The FDA announced the official launch of its Adverse Event Monitoring System (AEMS), consolidating product-specific systems including FAERS, VAERS, and AERS into a unified platform. The agency expects to save approximately $120 million over five years from the integration of systems that collectively cost $37 million annually to operate.
National Drug Code system expands to 12-digit format 💊 — The FDA published a final rule adopting new standards for National Drug Codes to address the imminent shortage of available 10-digit numbers. The regulation includes a seven-year implementation timeline plus three additional years, allowing existing products to add leading zeroes to their current NDCs, and also permits nonlinear barcodes.
VRBPAC unanimously endorses WHO flu strain selections 💊 — The FDA’s Vaccines and Related Biological Products Advisory Committee endorsed the World Health Organization’s recommendations updating all three trivalent vaccine components for the 2026-2027 influenza season.
FDA escalates war of words with uniQure over Huntington’s therapy 💊 — A senior FDA official called uniQure’s AMT-130 a “failed therapy” and accused the company of lying about prior interactions during a background call with news organizations. The agency reaffirmed its demands for a randomized, double-blind study with a sham surgery control, despite the company’s external control group data from a three-year analysis.
Makary continues pushing OTC expansion agenda 💊 — Speaking at the HHS inaugural women’s health conference, Commissioner Makary repeated his interest in moving prescription drugs to over-the-counter status, specifically mentioning plans for vaginal estrogen. Makary emphasized the need to “get away from paternalism and trust women and trust Americans” while referencing his broader “mass transition” vision.
FDA publishes new guidance on Form 483 responses 💊 — The agency released draft guidance explaining how drug companies should respond to good manufacturing practice inspection findings, emphasizing thorough investigation, risk assessment, appropriate actions like recalls, and root cause identification to prevent Warning Letter issuance.
FDA softens approach to desiccated thyroid medications 💊 — The agency announced plans to issue draft guidance by August 2026 regarding compliance priorities for unapproved animal-derived thyroid medications, marking a retreat from former CDER Director George Tidmarsh’s aggressive removal timeline. The FDA committed to ensuring patient safety “while manufacturers are working toward FDA approval.”
Leucovorin approval is dramatically narrower than earlier promises 💊 — The FDA approved an expanded indication for leucovorin calcium only for adult and pediatric patients with cerebral folate deficiency who have confirmed FOLR1 gene variants, a far cry from Commissioner Makary’s earlier claim that “hundreds of thousands of kids will benefit” from autism spectrum disorder treatment.
FDA rejects accelerated pathway for aging-related therapies 💊 — The agency denied Age Reversal Unity citizen petition requesting a nine-month expedited clinical trials framework for aging therapeutics, stating it “does not believe issuing such a one-size-fits-all framework is scientifically appropriate or in the best interests of public health.”
Compliance and Enforcement
Massive GLP-1 compounding crackdown begins 💊 — The FDA sent 30 Warning Letters to telehealth companies for making false or misleading claims about compounded GLP-1 products, citing companies for implying they were compounders when products were made by other pharmacies and for claiming their products were “same” or “generic” to FDA-approved treatments like Ozempic and Zepbound.
Medical device executive pleads guilty to withholding adverse events 💉 — The Department of Justice announced that ExThera Medical’s former chief regulatory officer Sanja Ilic agreed to plead guilty to failing to file adverse event reports with intent to defraud the FDA regarding blood filtration devices used on cancer patients. Ilic faces maximum three years prison and $250,000 fine.
Court supports FDA withholding of vaccine autopsy records 💊 — Judge Colleen Kollar-Kotelly granted the FDA summary judgment in Freedom of Information Act case, finding the agency “properly withheld autopsy reports in their entirety” from Informed Consent Action Network requests related to Covid-19 vaccine adverse events, citing medical privacy exemptions.
Governing
Senate Johnson launches FDA rare disease investigation 💊 — Sen. Ron Johnson announced launching Permanent Subcommittee on Investigations inquiry into recent FDA decisions that “scuttled development of certain rare disease drugs,” claiming he learned there’s a “black list within the FDA of companies who make too much noise” and vowing to examine Complete Response Letter reasoning.
ACIP abandons planned attack on mRNA vaccines 💊 — The Washington Post reports that the CDC’s Advisory Committee on Immunization Practices “abandoned an attack on COVID-19 mRNA vaccines” and no longer plans to vote against recommending mRNA shots, following Commissioner Makary’s opposition to ACIP member Robert Malone’s original plan.
Former FDA leaders support contraceptive safety in court brief 💊 — Margaret Hamburg, Stephen Ostroff, and Peter Lurie filed an amicus brief with the 3rd Circuit Court of Appeals supporting FDA-approved contraceptives in Pennsylvania v. Trump case, emphasizing the need for accurate information about the FDA’s scientific evaluations not to be “improperly disregarded.”
Hawley introduces legislation to withdraw mifepristone 💊 — Sen. Josh Hawley introduced S.4066 that would remove mifepristone from the market under withdrawn drug determination and make distribution violations of the Federal Food, Drug and Cosmetic Act. Companion House legislation by Rep. Diana Harshbarger is forthcoming, though Senate passage is unlikely due to a Democratic filibuster threat.
Other
Disc Medicine lays off 20% of staff following CNPV rejection 💊 — The company announced workforce reduction to preserve the ability to pursue “strategic priorities” after receiving a Complete Response Letter for bitopertin despite selection for the Commissioner’s National Priority Voucher program. The unusual outcome raises questions about the FDA’s initial enthusiasm versus subsequent clinical data assessment.
UniQure shares plunge following FDA meeting minutes 💊 — Company stock fell more than one-third after releasing Type A meeting minutes from January 30 showing FDA doesn’t agree that Phase 1/2 data with external controls provide primary effectiveness evidence. UniQure plans to request a Type B meeting to discuss study design options.
Everyone Medicines shuts down, citing inadequate FDA pathway 💊 — A biotech company developing individualized therapies announced closure after determining the FDA’s Plausible Mechanism Pathway “didn’t go far enough to make commercialization of custom drugs feasible, preferring the UK’s Medicines and Healthcare Products Regulatory Agency approach instead.
GSK receives RSV vaccine supplemental approval 💊 — CBER approved expanded indication for GSK’s respiratory syncytial virus vaccine to include adults aged 18-49 at increased risk of lower respiratory tract disease, expanding from current approval for persons 60+ and at-risk adults 50-59.
EPA proposes walking back ethylene oxide sterilization rule 💉 — The Environmental Protection Agency announced a new proposal reversing the Biden administration’s severe EtO restrictions, giving facilities a choice between new monitoring systems or adjusted technology review standards for facilities using more than ten tons annually, with a 45-day comment period once published.
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