RA/QA News Roll: Late June 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 reaches its final stages: The White House is reviewing a handful of potential nominees for FDA commissioner, and a person familiar with the search told POLITICO the goal was to make a pick this week. Several names surfaced over the two weeks: Bloomberg reported that White House policy aide and physician Heidi Overton is among the finalists, and later added New York Cancer & Blood Specialists CEO Jeff Vacirca. Axios also named Vacirca, Overton, and Principal Deputy Assistant Secretary of Defense for Health Affairs Stephen Ferrara. Norman “Ned” Sharpless and Alkermes CEO Richard Pops remain under consideration, and RBC analysts floated BIO CEO John Crowley and Ferrara. Overton previously coauthored academic papers with former Commissioner Martin Makary at Johns Hopkins.
Administration vetting a full senior leadership team: Alongside commissioner candidates, the White House is reportedly vetting candidates to lead the drug and biologics centers, currently run on an interim basis by Mike Davis and Karim Mikhail. People familiar with the search told Bloomberg the administration aims to announce a senior leadership team alongside the commissioner nominee, and that former Oncology Center of Excellence Director Richard Pazdur is under consideration to return as a senior agency leader.
Office of Therapeutic Products acting director to depart: 💊 Vijay Kumar will leave his post as acting director of the Office of Therapeutic Products, the super office responsible for cellular therapies, gene therapies, therapeutic vaccines, and plasma-derived products. Kumar wrote that he and agency leadership mutually decided not to renew his detail. He worked closely with former CBER Director Vinay Prasad and former Commissioner Makary and cosigned new policies on CAR T-cell therapies and manufacturing flexibility. OTP was led by Nicole Verdun until Prasad placed her on administrative leave about a year ago.
Trump nominates Klomp as HHS deputy secretary: President Trump is nominating HHS Chief Counselor Chris Klomp, who also serves as director of Medicare and CMS deputy administrator, to be HHS deputy secretary. Klomp has already exercised authority over the FDA as chief counselor, and POLITICO reported he was involved in Makary’s ouster and the elevation of former Principal Deputy Commissioner Sara Brenner to Kennedy’s senior counselor for public health. Confirmation would give him greater oversight of the FDA. Sen. Bill Cassidy (R-La.), whose committee would vet him, gave the pick a positive review.
FDA and MHRA to embed liaison officers in each other’s headquarters: At the Drug Information Association meeting, U.K. MHRA CEO Lawrence Tallon and FDA deputy commissioner for policy Grace Graham introduced an initiative to establish reciprocal liaison roles. An FDA representative will be embedded at MHRA headquarters in London, and an MHRA representative at the FDA’s White Oak campus. This follows an April announcement of closer cooperation on medical devices and the MHRA’s recent hiring of several former FDA digital health leaders.
FDA and African Medicines Agency sign a cooperation statement: 💊 Also at DIA, Associate Commissioner for Global Policy and Strategy Mark Abdoo announced that the FDA and the African Medicines Agency signed a Statement of Cooperation to strengthen engagement on regulatory and scientific matters related to the products both regulate.
Acting leaders emphasize continuity and staffing at DIA: Acting CDER Director Mike Davis said at a DIA town hall we attended that his top priority is delivering on the agency’s mission and that trust and integrity matter at a time of headwinds. He focused on staff retention and hiring and encouraged former employees to consider returning. Oncology Center of Excellence Director Angelo De Claro said advisory committees remain an important part of the review process and that the commissioner’s office supports convening ODAC meetings when the center wants to. Associate Commissioner for Legislative Affairs Brian Fahey described how the past year leaned on Complete Response Letters as a de facto advisory committee mechanism.
FDA General
FDA launches Operation TrialBlazer to keep clinical trials in the U.S.: 💊 On June 22, the FDA rolled out its part of a broader HHS initiative meant to reverse the shift of early clinical research to countries such as China and Australia. The FDA’s contribution includes guidance revisions, new sponsor resources, and a planned pilot program aimed at speeding first-in-human trials and streamlining later-stage testing. The effort also involves the NIH, ARPA-H, and the Office of the National Coordinator for Health IT. Kennedy introduced the initiative in a Fox News op-ed. The medtech side is not yet included: the roadmap does not mention device issues or the Investigational Device Exemption system, so for now the effort is focused on drug policy.
Phase 1 IND pilot in the works: 💊 Central to the effort is a proposed pilot to expedite Investigational New Drug applications. The FDA wrote in a request for information that accelerating early development in the U.S. requires reimagining the IND process. The pilot would recruit external research institutions to provide advice and preliminary review of sponsors’ IND submissions, and would explore rolling IND submissions that let the agency review completed components before the full application arrives.
Research and evidence guidance overhaul accompanies the launch: 💊 As part of Operation TrialBlazer, the FDA issued three draft guidances and an RFI. The revised master protocols guidance adds about 10 pages clarifying the agency’s thinking on basket trials, informed consent, and how trials with sub-studies should handle IND applications, and is open for comment through August 24. A revised draft guidance on first-in-human dose selection using quantitative systems pharmacology relies on the ICH M15 framework with QSP-specific considerations.
White House clears the substantial evidence guidance update: 💊 The Office of Information and Regulatory Affairs completed its review of the FDA’s revised draft guidance on demonstrating substantial evidence of effectiveness, marking it consistent with change, which clears the way for publication. The update to the December 2019 draft endorses one adequate and well-controlled trial plus confirmatory evidence as a viable norm, following the policy Makary and Prasad outlined in a February NEJM piece. Last year, 59% of new medicines approved by the agency’s main review office listed just one pivotal study in their original labeling. The guidance is open for comment through September 22.
PreCheck pilot participants selected: 💊 The FDA chose seven drug companies building U.S. manufacturing plants for its PreCheck pilot, which promotes domestic production: Eli Lilly, Regeneron, Kyowa Kirin, Amneal Pharmaceutical, Cellares, Fujifilm Biotechnologies, and Kriya Therapeutics. The seven were selected from more than 80 requests. Participants will receive technical guidance as they build facilities and enhanced engagement with earlier inspections when they submit applications referencing those sites. Three facilities are in North Carolina, two in New York, and one each in New Jersey and Indiana. Pre-operational engagements begin July 1.
White House clears the expedited IND RFI and a QSP dosing guidance: 💊 OIRA cleared the RFI for the expedited IND pilot, submitted June 3, on June 17. It also cleared a draft guidance on using quantitative systems pharmacology for dose selection in first-in-human trials, an unusually fast turnaround given it was received June 15. The QSP guidance was not on the drug centers’ guidance agendas for the year.
Advisory committee returns for two previously rejected drugs: 💊 The FDA plans to convene the Cellular, Tissue, and Gene Therapies Advisory Committee on July 29 to discuss Capricor’s Duchenne muscular dystrophy therapy deramiocel, rejected last July, and separately accepted Replimune’s resubmission of the melanoma immunotherapy RP1, rejected twice before, with an advisory meeting planned for late July. The agency expects to decide on RP1 by August 2 and deramiocel by August 22. The plans suggest advisory committees may play a larger role than they did under Makary.
FDA schedules a peptide compounding advisory meeting, and staff weigh against the peptides: 💊 Documents posted June 29 show FDA scientists concluded that publicly available data weigh against adding seven peptides, including BPC-157, TB-500, and MOTs-C, to the 503A bulks list that would let compounding pharmacies make them from bulk substance. None are components of approved drugs. All seven were previously flagged for potential safety risks before the agency removed them from that category in mid-April at Kennedy’s encouragement. The Pharmacy Compounding Advisory Committee meets July 23-24, with a roster that includes physicians and pharmacists who have promoted peptides, among them Robert Harshbarger, son of Rep. Diana Harshbarger (R-Tenn.), who urged Kennedy to hold the meeting.
New technical guidance on immunogenicity datasets: 💊 The FDA released a final Level 2 technical specification on submitting clinical trial datasets evaluating the impact of immunogenicity on drug pharmacokinetics, describing recommendations for three datasets in CDISC’s SDTM and ADaM formats.