RA/QA News Roll: Late 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
MAHA poll puts pressure on Makary and Kennedy — A new POLITICO poll found that 41% of Trump voters believe the president has not done enough to advance the Make America Healthy Again agenda, compared to 40% who feel he has. Overall, 52% of all respondents felt Trump had not done enough. The results are likely to put pressure on HHS officials, including Secretary Kennedy and Commissioner Makary, to take more visible action on MAHA-related issues, though such actions could risk angering traditional Republican constituencies opposed to increased regulation.
HHS Chief Counselor acknowledges FDA turnover concerns — At the STAT News Breakthrough Summit East, HHS Chief Counselor Chris Klomp offered notable remarks on turmoil at the FDA, stating that high-performing teams require trust built over time. He acknowledged that if the agency’s staff “replenishment rate” is exceeded, it takes longer for teams to work well together and drive reform. His comments suggest that HHS leadership is aware that senior-level turnover is affecting the FDA’s ability to meet reform objectives.
Washington Times editorial board has it out for Makary — The Washington Times’ editorial board published a scathing editorial pointing to a lengthy list of managerial issues that it says are undermining public confidence in the agency and not meeting the needs of President Trump.
FDA rushes compounding information collection through White House 💊 — The White House signed off on an extension of an information collection related to 503A and 503B compounding pharmacies after the FDA acknowledged that staffing adjustments had significantly impacted its ability to publish documents in the Federal Register on time, an unusual admission of procedural disruption caused by workforce reductions.
FDA General
Public hearing announced for CNPV program 💊 — The FDA announced it will hold a public hearing on June 12 to solicit feedback about the Commissioner’s National Priority Voucher program. A Federal Register notice provided additional details, including that the one- to two-month review targets do not include prefiling reviews. Requests to speak are due May 1, and comments will be accepted through June 29. Given the significant scrutiny this program has received, the hearing is expected to draw substantial public interest.
FDA pushing mass transition to nonprescription drugs 💊 — The FDA is signaling that efforts to move prescription drugs to over-the-counter status are likely to accelerate. On April 23, the agency will host a public meeting at the National Press Club on increasing access to nonprescription drugs, seeking input from drug developers, healthcare professionals, and consumers on practical considerations that shape nonprescription drug access.
FDA reclassifies melanoma detection devices 💉 — The FDA announced it is reclassifying optical skin lesion analyzers for detecting melanoma from Class III to Class II, allowing the devices to be marketed through the less burdensome 510(k) pathway rather than Premarket Approval. The devices are also being renamed as “software-aided adjunctive diagnostic devices for use on skin lesions.”
AI to accelerate drug filing reviews by up to 25% 💊 — Commissioner Makary indicated at the American Health Insurance Providers conference that the FDA plans to use artificial intelligence to dramatically shorten the two-month “filing review” period that precedes the formal review of new drug applications. An FDA spokesperson confirmed that a successful pilot demonstrated this step could be reduced from months to minutes, potentially accelerating standard drug approvals by roughly 17% (from 12 months to 10) and priority approvals by 25% (from eight months to six).
OMUFA facility fees drop by nearly 50% 💊 — Facility fees under the FDA’s Over-the-Counter Monograph User Fee Program for fiscal year 2026 are decreasing by approximately 49% compared to the prior year. Monograph drug facilities will be assessed $19,188, while contract manufacturing organizations will be assessed $12,792. The decrease is driven by the removal of supplementary adjustments that were initially intended to launch the program.
New nonanimal testing guidance released 💊 — The FDA published a new draft guidance on New Approach Methodologies (NAMs), titled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The guidance describes how drug developers can validate the use of non-animal testing approaches, including defining a test’s context of use, biological relevance, and fitness for purpose. Notably, the guidance does not apply to biologics. Separately, the NIH announced a $150 million investment to develop and scale NAMs.
FDA proposes reclassification of tuberculosis diagnostic tests 💉 — The FDA proposed reclassifying two types of tuberculosis diagnostic tests — cell-mediated immunity tests and cell-mediated immune response enzyme-linked immunospot tests — from Class III to Class II, which would allow them to be marketed through the 510(k) pathway.
FDA classifies blood irradiator devices 💉 — The FDA proposed classifying blood irradiator devices under Class II for products intended to prevent transfusion-associated graft-versus-host disease and Class III for those intended to prevent metastasis.
New guidance on topical drug product characterization 💊 — The FDA published a final guidance on physicochemical and structural (Q3) characterization of topical drug products submitted in abbreviated new drug applications. The guidance describes how generic drug developers can demonstrate sameness, similarity, or difference in Q3 attributes between test products and reference standards, particularly for topical products, where achieving the same look and feel as a reference product can be challenging.
Revised Q&A guidance on pyrogen and endotoxin testing 💊 — The FDA issued a revision to its 2012 final Q&A guidance on pyrogen and endotoxin testing, updating the agency’s expectations in line with revised U.S. Pharmacopeia publications and offering recommendations on reagents not derived from animals. The revision aligns with the FDA’s broader push to reduce reliance on animal testing.
Patient preference guidance clears White House review 💉 — The FDA’s long-awaited update to its 2016 guidance on the regulatory use of patient preference information was s published on March 27. The guidance, a commitment under MDUFA V, provides updated recommendations for companies that want to provide the FDA with information on patients’ treatment preferences, including how to design studies, obtain FDA feedback, and include that information in device labeling.
Final guidance on weight-loss devices published 💉 — The FDA published a final guidance combining two earlier draft documents on premarket considerations for medical devices with indications for weight loss, with updates touted as part of the Make America Healthy Again agenda.
CBER director position posted 💊 — With CBER Director Vinay Prasad set to step down in April, the FDA posted the position on USAJobs, with a salary range of $301,825 to $400,000 per year. Applications are open through April 3.
Top infectious disease regulator departing 💊 — Adam Sherwat, director of CDER’s Office of Infectious Diseases, is set to leave the FDA on April 4. Andrew LeBoeuf, CDER’s associate director for regulatory strategy, will also depart in early April.
Generic drug approvals for February 💊 — The FDA’s Office of Generic Drugs approved 64 new generic drugs in February, the highest monthly total so far this fiscal year, including six first-time generics. Another 26 generics received tentative approval.
FDA’s real-time surveillance wish list 💊 💉 — A new contracting notice from the FDA indicates the agency is seeking commercial capabilities for real-time or near-real-time safety signals to complement its existing surveillance systems, including Sentinel and the Adverse Event Reporting System. Commissioner Makary has indicated that enhanced surveillance capabilities could support faster approvals using single-trial approaches.
Ideas for the plausible mechanism pathway 💊 — A new paper authored by former FDA Commissioner Scott Gottlieb and Morgan Lewis law partner Maarika Kimbrell argues that the FDA should better define regulatory boundaries for grouping multiple genetic variants under a single approval within the plausible mechanism pathway. They also call for greater clarity around manufacturing personalized therapies and more information about how the FDA plans to extrapolate safety and efficacy beyond submitted data.
FDA rejects superhuman drug pathway and one-year cancer trial limit 💊 — The FDA rejected two citizen petitions from Age Reversal Unity’s Ali Afshar, one requesting a regulatory pathway for drugs intended to produce “superhuman” enhancements and another seeking to limit all cancer clinical trials to a maximum of one year. The agency said its current regulatory pathways are sufficient to evaluate drugs with structure/function claims and that a one-year trial limit would be contrary to public health.
De Novo authorization for choking rescue device 💉 — The FDA granted a De Novo request for the LifeVac device as a second-line treatment for choking, establishing a new Class II device category. The authorization was accompanied by an FDA safety communication reminding the public of established choking rescue protocols, specifying that anti-choking devices should be used only after unsuccessful basic life support measures.
FDA says alternative funding programs cannot import drugs 💊 — The FDA responded to a 2024 citizen petition, clarifying that so-called “alternative funding programs” — third-party companies that partner with employer-sponsored health plans to require employees to import prescription drugs from outside the U.S. — are not permitted to import drugs under the agency’s importation programs.
FDA conference on innovative regulatory strategies — The FDA announced it will hold a conference on May 19-20 focused on innovative regulatory strategies to advance medical products, covering advanced drug manufacturing, artificial intelligence, digital health technologies, and analytical methods for benefit-risk determinations.
Upcoming webinar on blood and plasma applications 💊 — The FDA announced plans to hold a webinar on May 12 focused on its review of biologics license applications for blood and source plasma.
Compliance and Enforcement
Unannounced foreign inspections increased 45% in FY 2025 💊 💉 — In response to questions from POLITICO’s AgencyIQ, the FDA reported that it conducted 233 unannounced foreign inspections in fiscal year 2025, approximately 45% more than the 161 conducted in FY 2024. Despite the increase, about 90% of the agency’s 2,370 foreign inspections in FY 2025 were still declared beforehand. Inspections took place in at least 21 countries, including China and India, though about three-quarters involved food or cosmetics facilities.
Warning letters now include photographic evidence 💊 💉 — A warning letter to Patcos Cosmetics of India referencing an unannounced inspection included photographic evidence of unsanitary conditions at the facility, something not previously seen in FDA warning letters. While the photos were partially redacted, the inclusion signals that the agency sees value in releasing visual evidence in select enforcement actions.
