RA/QA News Roll: Mid May 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
These RA/QA news rolls are available in full only to paid subscribers. Upgrade here.
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.
If you haven’t upgraded to a paid subscription yet, you can do so here. Also, make sure to follow us on LinkedIn and catch the latest episodes of our podcast, The Life Science Rundown.
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
Makary resigns; Diamantas takes over as acting commissioner — FDA Commissioner Martin Makary resigned on May 12 after weeks of pressure from HHS leadership. HHS Secretary Kennedy, not the White House, ultimately made the call. Kyle Diamantas, the agency’s deputy commissioner for food and an HHS senior counselor, is now acting commissioner. Diamantas is a former Jones Day partner who focused on FDA regulatory matters, is reported to be close to the Trump family, and has generally been well-regarded by FDA staff. Among his first meetings as acting commissioner was one with the president of March for Life, a signal that he’s working to repair relationships with antiabortion groups that had called for Makary’s removal.
White House targets early June for new FDA commissioner pick — Senior health officials in the Trump administration are aiming to select Makary’s permanent successor within weeks. The search is in early stages but officials plan to narrow the list quickly. Several names have been discussed publicly, including former acting commissioner Sara Brenner, ophthalmologist Houman Hemmati, and former commissioners Stephen Hahn and Brett Giroir, though each faces confirmation challenges. The position requires Senate confirmation, and HELP Committee Chair Bill Cassidy (R-La.) has indicated the next nominee must have an M.D. or Ph.D. and demonstrate commitment to antiabortion priorities. Sen. Josh Hawley (R-Mo.) has also signaled that mifepristone will be a litmus test. With midterm elections approaching, the acting commissioner is likely to remain in place through the end of the year.
More FDA leaders expected to exit — Reuters reported that CDER Acting Director Tracy Beth Høeg is likely to leave soon, with Bloomberg later reporting her departure was expected immediately. Chief of Staff Jim Traficant, Deputy Chief of Staff Samuel Doran, and Associate Director of Policy and Research Strategy Sanjula Jain-Nagpal are also expected to depart.
Multiple acting leaders across the FDA — Several of the agency’s most important positions are filled on a temporary basis. Katherine Szarama is acting CBER director following Vinay Prasad’s departure. CDER continues under Tracy Beth Høeg on an acting basis (though her departure is expected). Mallika Mundkur is acting chief medical and scientific officer. R. Angelo de Claro became the permanent director of the Oncology Center of Excellence, the only major center to name a permanent leader in recent weeks.
CBER director search continues 💊 — The FDA is looking at three or four finalists for the CBER director position, with Houman Hemmati among them. Szarama, the current acting director, is not in the running. The Wall Street Journal reported that Makary’s preference for hiring Hemmati had been blocked by the White House and senior health officials in recent weeks. BIO CEO John Crowley said the FDA had reached out to industry groups and patient organizations for input on the search.
HHS investigating vaccine-chronic disease links 💊 — The New York Times separately reported that HHS Secretary Kennedy is pushing government scientists and federal data contractors to examine his long-held theory that vaccines help fuel chronic disease, with assistance from FDA and CDC career officials and contractors with access to millions of patient records. Former FDA Principal Deputy Commissioner Sara Brenner is expected to help lead the effort in her new HHS role.
FDA’s hiring numbers keep climbing — At the Milken Institute Global Conference, Makary said the agency is now hiring 3,000 new scientists, up from the 2,000 figure he cited just weeks earlier and the original 1,000. Whether this hiring effort continues without his active support is an open question.
HHS considering ban on some antidepressants 💊 — Reuters reported that HHS officials are actively exploring whether they can ban certain selective serotonin reuptake inhibitors (SSRIs). HHS disputed the reporting, though the department recently announced a MAHA Action Plan to Curb Psychiatric Overprescribing, which calls for agencies to evaluate prescription patterns for psychiatric medications and elevate nonmedication treatments.
SSRI labeling petitions under FDA review 💊 — CDER’s deputy center director for substance use and behavioral health, Marta Sokolowska, said at the MAHA overmedication summit that the FDA is currently evaluating about five citizen petitions requesting revision of SSRI labeling related to adverse effects, along with additional information from literature and other databases.
Trump pushing for approval of natural kratom 💊 — President Trump told reporters he is “looking very seriously at natural 7-OH and getting that approved.” This would be a significant departure from the FDA’s prior statements and warnings about 7-OH, an alkaloid compound the agency has said has potential for abuse because of its ability to bind to opioid receptors.
FDA General
Single-day, AI-prioritized inspection pilot launched 💊 💉 — At the FDLI Annual Conference, Commissioner Makary (before his resignation) announced a pilot program for one-day screening inspections at manufacturing facilities identified as low-risk by AI. Full inspections typically take several days. The new screening assessments are intended to complement full inspections as part of a risk-based approach. If safety issues surface during a one-day screening, inspectors can extend the visit. The pilot is expected to continue throughout 2026.
IND reform plans detailed 💊 — Makary outlined plans for large-scale reform of IND and Phase 1 clinical trial processes at FDLI. The FDA is interested in piloting a three-to-six-month timeline from pre-IND counseling request to IND submission. The agency plans to publish a list of information it does not require in IND submissions and is looking at cutting or deferring requirements unrelated to safety. Makary also reiterated interest in reforming the institutional review board process.
Real-time clinical trials pilot draws interest 💊 — Fifteen companies have signaled interest in participating in the real-time clinical trial reporting pilot. The FDA held a Q&A session on May 15 where Chief AI Officer Jeremy Walsh clarified that the pilot is not interested in patient-level data but rather prespecified signals about what’s happening in a trial. The agency plans to share selection criteria in July and complete selections in August.
Digital health technology submissions guidance 💉 — The FDA issued a technical specification on how drug sponsors should present continuous glucose monitor data in submissions, including guidance on CDISC standards, time horizons, and traceability expectations.
Plausible mechanism pathway draws tons of comments 💊 — The FDA received over 150 comments on its draft plausible mechanism pathway guidance. Multiple stakeholders expressed confusion about which diseases and drugs would be eligible. The American Society of Gene and Cell Therapy noted the guidance at times appears focused on ultra-rare diseases while other language suggests broader applicability. PhRMA recommended broadening the eligible diseases and products.
Patient Listening Session summaries coming — The FDA updated its Patient Listening Session webpage, noting that summaries are coming soon for four 2026 meetings on CACNA1A, SCN8A-related disorders, idiopathic pulmonary fibrosis, and primary sclerosing cholangitis.
Cell and gene therapy CMC guidance finalized 💊 — The FDA quietly published a final guidance on chemistry, manufacturing, and controls flexibilities for developing human cellular and gene therapy products. The 10-page document is a direct-to-final guidance that formalizes the agency’s January 2026 announcement on flexible requirements for cell and gene therapies.
New draft genome editing safety guidance 💊 — The FDA released a draft guidance on using next-generation sequencing to assess the safety of genome editing therapies, broadening the definition of genome editing products to include those modifying the epigenome or transcriptome.
RAPID coverage pathway details emerge 💉 — At the Medical Device Innovation Consortium’s Innovations in Evidence Summit, CDRH Director Michelle Tarver and CMS Chief Medical Officer Dora Hughes provided more detail on the joint FDA/CMS RAPID pilot for breakthrough device coverage. Tarver confirmed that companies will receive written feedback from both agencies that they can share with investors and consultants. Hughes said CMS is working to publish more resources on the coverage process. Expert analysis from outside law firms found the program valuable for qualifying sponsors but noted that key implementation details remain pending.
Interoperability roadmap coming from CDRH 💉 — CDRH Director Tarver said at FDLI that the center is working on a discussion paper covering interoperability standards across the medical device, electronic health record, and consumer tech sectors.
CDRH joins Rare Disease Innovation Hub 💉 — CDRH is now officially part of the FDA’s Rare Disease Innovation Hub, making it a three-center co-chaired effort alongside CDER and CBER. Hub Director Amy Comstock Rick noted that CDRH participation could help sponsors evaluate disease measurements in pediatric R&D.
Drug repurposing push 💊 — The FDA published a call for input on disease areas with significant unmet need where existing evidence may support a new use for an approved drug, as well as cases with promising preliminary data. The agency is also looking to facilitate repurposing opportunities alongside the NIH and CMS.
Kidney safety biomarker incubator 💊 — The FDA announced a new regulatory science initiative focused on advancing biomarkers for drug-induced kidney injury. The Biomarker Incubator will aggregate data from multiple sources to validate biomarkers, and the agency is requesting voluntary submission of human data for the pilot phase.
CDRH promotes Experiential Learning Program 💉 — CDRH opened its 2026 proposal submission cycle for the Experiential Learning Program, which allows industry to invite center staff for tours of duty in their companies. Priorities this year include the Home as a Health Care Hub initiative, designing devices for home environments, and medical device interoperability.
Obesity and drug dosing: FDA seeks input 💊 — The FDA is requesting comments on how obesity affects the pharmacokinetics and pharmacodynamics of experimental medicines, citing low enrollment of obese patients in clinical trials. Comments are open through June.
FDA updates surrogate endpoints table 💊 — The FDA quietly updated its table of surrogate endpoints used as the basis for drug or biologic approval, a required resource that helps stakeholders evaluate which surrogates the agency has historically accepted.
eSTAR FAQ updates 💉 — CDRH updated the eSTAR webpage with new FAQs covering submission requirements, version updates, and attachments. The templates themselves have not yet been updated.
READI-Home webinar scheduled 💉 — The FDA announced a June 24 webinar on its READI-Home Innovation Challenge for medical devices intended to reduce hospital readmissions.
PreCheck program deadline passed 💊 — May 1 was the deadline for finalists in the Commissioner’s FDA PreCheck Program to submit follow-up information. The FDA will review packages and make selections by June 30, with a July 1 start for pre-operational engagement.
GLP-1 generics workshop scheduled 💊 — The FDA and the Center for Research on Complex Generics will cohost a September 23-24 workshop on the GLP-1 generic drug pathway, covering product-specific guidance, bioequivalence studies, and manufacturing considerations for drug-device combination products.
Record month for generic approvals 💊 — The Office of Generic Drugs approved 85 generics in April, the most in a single month since August 2023 and the second-best month in the last five years. Forty-one were first-time generics.