RA/QA News Roll: Mid 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
Diamantas is not interested in keeping the top job long term: Acting Commissioner Kyle Diamantas does not want to hold the role permanently, according to reporting from Endpoints News. Because the FDA commissioner is a Senate-confirmed position, his acting tenure is governed by the Vacancies Act of 1998, which generally limits an acting official to 210 days from the date the vacancy occurred, putting his window at around early December. That clock pauses once a formal nomination is submitted and resets if a nomination is rejected, withdrawn, or returned. Diamantas previously served as deputy commissioner for food, a role now held by Donald Prater in an acting capacity.
Sharpless and Pops reported on the commissioner short list: The administration appears to be working from a short list for the permanent commissioner job. CNN reported that former acting commissioner and National Cancer Institute director Norman “Ned” Sharpless and Alkermes chairman and CEO Richard Pops are both under consideration, with some support also voiced for keeping Diamantas. An announcement on a formal nominee is reportedly still weeks away. Whoever takes the role will inherit an agency where many senior positions, including the directors of CDER and CBER, are filled on an acting basis.
Diamantas keeps a low public profile but an active stakeholder schedule: Since taking over, Diamantas has stuck to official channels rather than the frequent podcast appearances his predecessor favored. Public calendars show him meeting with BIO, the Medical Device Manufacturers Association, Friends of Cancer Research, former Commissioner Mark McClellan, AdvaMed, PhRMA, and legislators who oversee the FDA. He also met with PhRMA head Stephen Ubl and Right to Try bill sponsor Rep. Diana Harshbarger (R-Tenn.), joined by policy deputy Grace Graham.
Diamantas pledges support for staff and more advisory committee meetings: At a June 3 meeting with rare disease advocacy groups, Diamantas voiced support for FDA reviewers and pledged to prevent interference with their decision-making, along with a renewed push to hire reviewers, including former agency employees. According to reporting from Endpoints News, he also indicated that more advisory committee meetings should be expected, reversing a slowdown during Makary’s tenure. The hiring pledge comes as the administration pursues a workforce policy that would make it easier to remove staff seen as out of step with its priorities.
Lisa Romano named inspections and investigations lead: The FDA promoted Lisa Romano to principal deputy associate commissioner for inspections and investigations. She previously served as acting in that role and before that as deputy director for the Medical Products Inspectorate.
White House counsel joined an FDA meeting with Replimune: Public calendar logs show that on May 27, two days before Replimune said it would resubmit its rejected melanoma drug RP1, the company’s CEO and head of regulatory affairs met with Deputy Commissioner for Strategic Initiatives Lowell Zeta and Chief Counsel Sean Keveney. White House associate counsel Joshua Hoyt also attended. The FDA’s second rejection of RP1 in mid-April drew significant pushback and contributed to the tensions that preceded Makary’s resignation. Replimune had separately met with the White House Domestic Policy Council in May to present its case.
Kennedy reportedly out of the loop on Høeg firing: A New York Times story describing HHS Secretary Robert F. Kennedy Jr.’s limited involvement in day-to-day management of his agencies cited the recent FDA leadership shake-up as an example. According to three people who spoke with the paper, Kennedy did not learn of Tracy Beth Høeg’s firing as acting CDER director until afterward.
Kennedy uses his podcast to press on peptides: A June 10 episode of Kennedy’s podcast featured a biohacking influencer who described personally using several peptides that the FDA recently removed from the 503A bulks nomination list. Those peptides are on the agenda for upcoming Pharmacy Compounding Advisory Committee meetings, one in July and another by the end of February. Their removal was unusual given that the agency had previously cited safety concerns. Kennedy has continued to push the FDA to loosen restrictions on compounded peptides.
New executive order reshapes the federal workforce: President Trump signed an executive order converting some policymaking roles into “Schedule Policy/Career” positions, removing certain protections such as adverse action procedures and appeals and allowing for faster termination. The policy was known as “Schedule F” during the first Trump administration and could affect FDA staff.
FDA General
FDA finally publishes delayed gene therapy guidance: 💊 The FDA released “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing,” a guidance the White House had cleared back on March 31. The unusual delay had stood out for an otherwise uncontroversial document. The guidance explains how companies can use existing knowledge of a manufacturing platform or other public knowledge to advance development and improve review efficiency across multiple programs.
Revised guidance on company communications with payors: 💊💉 The FDA issued a revised version of its 2018 draft guidance on communicating health care economic information to payors and formulary committees. The update reconfirms that companies can share such information with these sophisticated audiences in ways that would be problematic if directed at doctors or patients, including for products not yet approved or cleared.
FDA adopts ICH M15 on model-informed drug development: 💊 The FDA formally adopted the International Council for Harmonisation’s M15 guideline on model-informed drug development, which the ICH adopted February 9.
New draft guidance on Forms FDA 3542 and 3542a: 💊 The FDA published a draft guidance answering 29 common questions about the forms used to submit patent information with a New Drug Application or after approval. The information feeds the FDA’s Orange Book listings, which carries significant implications for sponsors and generic competitors. The agency framed the release as part of its Drug Competition Action Plan.
ICH biannual assembly readout: 💊 The ICH Assembly held its biannual meeting and reported additions to its observer roster, approval of an ICH Strategic Vision document outlining priorities through 2030, and adoption of the ICH E6(R3) Annex 2. The readout noted progress on high-priority quality, efficacy, safety, and multidisciplinary guidelines, and said the MedDRA Version 29.0 Companion Document is expected later this year.
Two new CBER SOPP documents: 💊 CBER released Version 7 of SOPP 8401.1 on issuing and reviewing responses to information request communications for pending applications, and Version 11 of SOPP 8406 on processing PDUFA application payments.
FDA reorganizes and expands its real-world evidence pages: 💊💉 The FDA revamped its webpage on the use of real-world evidence in decision-making, the first update since the pages launched in September. The CDER page now lists 13 approvals using RWE and nearly 50 postmarket studies, and the device center’s newly incorporated page lists 138 device-specific regulatory uses of RWE. Formats and definitions were standardized across centers to allow some cross-comparison.
First in silico drug development tool accepted into ISTAND: 💊 The FDA accepted a letter of intent from Absentia Labs for a digital liver model that uses artificial intelligence to assess the liver injury risk of small-molecule candidates, the first in silico tool advanced into the agency’s ISTAND program. Acceptance is the first of three steps toward qualification, and the FDA raised 16 considerations for the developer to address. Read the FDA’s statement on it here.
FDA considering an expedited IND pilot: 💊 The White House is reviewing an FDA request for information on an “Expedited Investigational New Drug Pilot Program,” according to a notice from the Office of Information and Regulatory Affairs. The effort responds to concerns that early-stage trial activity is shifting to countries such as China and Australia. Lawmakers and the agency have proposed testing whether certain lower-risk early trials could launch with less oversight, with Australia’s clinical trial notification system cited as one possible model.
FDA reassesses the CNPV program after a public hearing: 💊 The FDA held a June 4 public hearing on the Commissioner’s National Priority Voucher program, with 17 drug company representatives, physicians, researchers, and patient advocates offering feedback. Deputy Chief Medical Officer Mallika Mundkur and acting CDER Director Mike Davis opened the session. Several speakers, including PhRMA’s Kelly Falconer Goldberg and former FDA official Lowell Schiller, urged the agency to add transparency and structure through guidance or notice-and-comment rulemaking, warning that informal selection criteria could invite legal challenges. The agency intends to continue the program but may change its processes, and is collecting comments through June 29.
FDA adds bemotrizinol to the sunscreen monograph: 💊 The FDA finalized an order adding bemotrizinol to its sunscreen monograph, the first new sunscreen active ingredient cleared for the U.S. market in roughly two decades. The ingredient, submitted by DSM-Firmenich under the CARES Act pathway, will be considered generally recognized as safe and effective at concentrations up to 6%. The ingredient has been authorized in Europe since 2000.
OTP town hall covers cell and gene therapy submissions: 💊 At a June 4 town hall, the FDA’s Office of Therapeutic Products fielded questions on cell and gene therapy BLA submissions, emphasizing the pre-BLA meeting. Staff described it as not required but highly recommended, advised requesting it at least four months before the anticipated BLA submission, and recommended a maximum of 10 questions for a 60-minute meeting.
