RA/QA News Roll: Late April 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
Brenner leaves FDA for HHS role — Sara Brenner, the FDA’s principal deputy commissioner and its former acting commissioner, is leaving the agency to become senior counselor for public health to HHS Secretary Kennedy. The move was reportedly orchestrated by HHS Chief Counselor Chris Klomp. It’s not yet clear who will replace Brenner, but whoever is selected could be seen as a potential successor to Commissioner Makary if he were to resign.
Ibogaine executive order signed at White House event 💊 — President Trump, joined by HHS Secretary Kennedy, Commissioner Makary, and podcaster Joe Rogan, signed an executive order to accelerate the development of ibogaine and other psychedelics for treating mental illness. The order instructs the FDA to provide Commissioner’s National Priority Vouchers to psychedelic drugs with Breakthrough Therapy designations, directs the FDA and DEA to establish a pathway for patient access under the Right to Try Act, and calls for rescheduling psychedelic substances that have completed Phase 3 trials. Rogan said he had directly texted Trump information about ibogaine for opioid use disorder and received a positive response.
Three new CNPVs for psychedelics 💊 — The FDA issued three new Commissioner’s National Priority Vouchers to psychedelic products: psilocybin for treatment-resistant depression (awarded to Compass Pathways for COMP360), psilocybin for major depressive disorder (to Usona Institute), and methylone for PTSD (to Transcend Therapeutics, being acquired by Otsuka Pharmaceutical). Compass also received rolling review status for its NDA. Commissioner Makary told CNBC that decisions on some psychedelic therapies could come as soon as this summer.
Makary on mRNA vaccine funding and universal flu shot 💊 — On CNN’s “The Source,” Commissioner Makary responded to questions about the cancellation of $500 million in HHS vaccine development projects, framing it as a shift in priorities rather than a cancellation. He argued that taxpayer dollars should fund research that the private sector will not, citing a universal flu shot as an example.
WSJ editorial board again criticizes Makary and Prasad 💊 — The Wall Street Journal’s editorial board published another editorial criticizing Commissioner Makary and CBER Director Vinay Prasad following the FDA’s second rejection of Replimune’s melanoma immunotherapy. The editorial alleged that Makary and Prasad had arranged a review designed to cover for their initial rejection of the drug and called on Congress to question both officials.
White House reviewing update to substantial evidence guidance 💊 — The White House Office of Information and Regulatory Affairs received revised draft guidance from the FDA on demonstrating substantial evidence of effectiveness for drugs and biologics. This would update 2019 draft guidance and follows Makary’s recent policy making one pivotal trial the FDA’s default standard for approval. Last year, 59% of new medicines approved by the FDA’s main review office listed just one pivotal study in their original labeling.
Kennedy launches HHS podcast — HHS Secretary Kennedy is starting The Secretary Kennedy Podcast, intended to feature interviews with guests who challenge medical “taboos.”
FDA General
First ibogaine IND cleared 💊 — The FDA cleared the first investigational new drug application for noribogaine hydrochloride as a potential treatment for alcohol use disorder, allowing early-phase human trials in the U.S. The IND went to DemeRx NB.
CNPV meeting rescheduled to June 4 💊 — The FDA confirmed the reschedule of its public meeting on the CNPV pilot program to June 4. The meeting will seek feedback on eligibility criteria, voucher selection processes, sponsor responsibilities, and program implementation.
FDA proposes enforcement policy for respiratory products 💉 — The FDA published a new draft guidance proposing not to enforce several medical device requirements for face-filtering respirators and reusable respirators already under NIOSH regulatory oversight, citing overlap between the two agencies.
FDA removes 12 peptides from safety concerns list 💊 — The FDA officially removed 12 peptides from a list of bulk drug substances that “raise significant safety concerns,” including emideltide, epitalon, Semax, and Melanotan II. The agency previously said it had concerns about immunogenicity risks and peptide-related impurities for many of these substances.
Compounded peptides meeting set for July 💊 — The FDA announced it will hold a meeting on July 23-24 on bulk compounding of certain peptide substances, including emideltide, Semax, and epitalon.
Overdue generic drug applications drop sharply 💊 — Speaking at the FDA’s annual Generic Drugs Forum, Office of Generic Drugs Deputy Director Darby Kozak disclosed that the number of generic drug applications pending more than 60 days past their goal date fell from nearly 70 in Q2 2025 to just two in Q2 2026. A new transparency pilot program providing more frequent updates to applicants is one factor driving improvement.
Continuous trial pilot launched 💊 — Commissioner Makary announced a new pilot program for real-time clinical trials at an event on the FDA’s White Oak campus. Two proof-of-concept studies are already underway: one sponsored by AstraZeneca testing a cancer drug combination in mantle-cell lymphoma, and another run by Amgen enrolling patients with small-cell lung cancer. Under the program, FDA reviewers would see clinical data in real time as it is generated. The FDA plans to publish a request for information in the Federal Register seeking industry input on the pilot, with final selection criteria expected in July and selections in August. FDA Chief AI Officer Jeremy Walsh and Deputy Chief Medical Officer Mallika Mundkur are leading the effort.
Petition challenges FDA’s release of Complete Response Letters 💊 — A citizen petition filed by Covington & Burling’s Krista Hessler Carver calls on the FDA to change its process for releasing CRLs, arguing the agency is acting unlawfully by disclosing commercially confidential information without offering sponsors the opportunity to redact sensitive content. The FDA recently asked Congress for additional legal authority to release CRLs, indicating the agency itself is concerned it may lack defensible authority.
ICER calls for accelerated approval reforms 💊 — The Institute for Clinical and Economic Review published a white paper calling for extensive changes to the FDA’s accelerated approval pathway, including requiring advisory committees, issuing after-action reports when confirmatory trials fail, creating risk ratings for accelerated approval products, and establishing a more structured process for developing surrogate endpoints.
Proposal to reduce CAR-T safety monitoring 💊 — A paper by a working group of industry, academic, and patient representatives argued that the FDA’s current 15-year posttreatment monitoring period for CAR-T cell therapy patients is no longer justified and should be shortened to five years, with streamlined data collection.
New antibiotics impurities guidance 💊 — The FDA published a new draft guidance on impurity specifications for antibiotics made using fermentation or semisynthetic methods, which can introduce a wider variety of impurities than chemical synthesis. Existing guidance documents do not cover these production methods.
Bioanalytical methods guidance for biomarkers 💊 — The FDA issued final recommendations on validating bioanalytical methods for biomarker assays, restating advice from 2018 guidelines that had been superseded by ICH M10 guidance in 2022 (which explicitly excluded biomarkers).
Animal testing reduction report card 💊 — The FDA published a press release citing six developments in the past year to reduce animal testing, including guidance on reducing nonhuman primate testing for monoclonal antibodies and transitioning away from horseshoe crab-based endotoxin testing. The agency still has not updated its animal testing regulations despite the 2022 FDA Modernization Act 2.0.
CDRH warns about nitrosamines in combination products 💉 — CDRH sent a letter to industry warning about potential nitrosamine impurities in device-led combination products, specifically citing detection in certain products containing the drug rifampin. The agency directed manufacturers to existing drug product guidance. No adverse events have been reported.
Hormonal contraceptive petition filed 💊 — The Contraceptive Study Group filed a citizen petition asking the FDA to add warnings to hormonally active contraceptives regarding potential autoimmune and inflammatory risks. The petition is notable because key figures in the MAHA movement, including Surgeon General nominee Casey Means, have previously said that birth control side effects are under-discussed.
MIDD mini review published 💊 — CDER’s Office of Clinical Pharmacology Director Issam Zineh published a narrative review on the history and regulatory impact of model-informed drug development. The paper reports that the FDA’s MIDD meeting program has saved approximately $1.6 billion and over a century of clinical development time since its establishment.
NDC final rule webinar announced 💊 — Following the FDA’s March finalization of a rule to shift from 10-digit to 12-digit National Drug Codes and allow nonlinear barcodes, Leavitt Partners announced a June 17 webinar to showcase a cross-sector implementation guide and 10-year roadmap.
Postmarketing requirements mostly on track 💊 — The FDA’s latest report on postmarketing requirements and commitments found that most are progressing on schedule, with 83% of open PMRs tied to biologics license applications and about two-thirds of those tied to new drug applications on track as of September 2024.
Nonprescription drugs meeting details 💊 — The FDA’s April 23 meeting on increasing access to nonprescription drugs, hosted by Duke-Margolis, was led by FDA nonprescription drug regulation lead Karen Murry. A discussion guide has been released covering key regulatory issues related to mass prescription-to-OTC conversion.