RA/QA News Roll: Late January 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
CNPV program faces multiple delays and criticism 💊 — Reuters reports the FDA extended reviews of at least two Commissioner’s National Priority Voucher medicines after staff raised safety and efficacy concerns. One review was delayed following a treatment-related death, while another’s deadline was pushed to February 10 amid questions about efficacy measures and abuse risks. Reviews of Boehringer’s zongertinib and Eli Lilly’s orforglipron are also taking “weeks or longer” than expected, undermining the program’s 1-2 month review promise.
Staff concerns mount over political interference in voucher reviews 💊 — AP reports concerns CNPV program “may run afoul of legal, ethical and scientific standards,” with some staffers told to “skip certain regulatory steps” for obesity pill reviews. Principal Deputy Commissioner Sara Brenner declined power to sign off on CNPV approvals, leaving authority with Deputy Chief Science Officer Mallika Mundkur. Selection decisions increasingly led by CBER Director Prasad “sometimes unbeknownst to FDA staff,” with reviewers learning from companies about Prasad’s voucher contacts.
Pazdur warns of breached firewall, proposes Federal Reserve-like structure 💊 — Former OCE Director Rick Pazdur said at STAT’s J.P. Morgan event that “firewall” separating review decisions from political influence has been “breached,” particularly in CNPV program lacking defined process and staff involvement. Pazdur proposed making the FDA apolitical through competitive hiring and term limits for commissioner/center director roles, warning that constant political changes will create a “chaotic situation of constant inconsistencies in approval standards.”
Makary joins Trump’s Great American Recovery Initiative 💊 — President Trump signed an executive order creating a drug addiction crisis coordination initiative, including the FDA Commissioner as a member alongside Cabinet officials. Makary said the FDA would be “going on offense against addiction” rather than reactive, including using priority vouchers for treatment access.
FDA General
GDUFA reauthorization proposes domestic manufacturing incentives 💊 — New meeting minutes reveal an FDA proposal to “waive annual facility fees for the first three years for companies that break ground in the U.S. to manufacture one or more finished generic drugs or active pharmaceutical ingredients domestically.” The agency also proposed increasing the foreign facility fee differential from $15,000 to $25,000 and granting priority review to generic companies that meet U.S. manufacturing conditions.
FDA launches ImportShield centralized review program — The agency replaced the Nationalized Entry Review Program with ImportShield, combining five regional teams into a centralized operation for “consistent oversight across all U.S. ports of entry,” developing an “advanced review platform system” for comprehensive information access while maintaining CBP connectivity.
Data fidelity issues could trigger 180-day review extensions 💊 — The FDA proposed extending generic drug review goal dates by 180 days when the agency “identifies data fidelity issues related to bioequivalence or bioanalytical data, or associated with a manufacturing facility,” providing time to “evaluate scope and impact” of problems.
CBER adds AI reviewer to IND process 💊 — The Center for Biologics released revised procedures showing “artificial intelligence reviewer” from Office of Biostatistics and Pharmacovigilance now involved in investigational new drug application review process, marking integration of AI tools in regulatory workflows.
Multiple myeloma guidance supports accelerated approval 💊 — The FDA published draft guidance stating that minimal residual disease can support accelerated approval for multiple myeloma medicines, though the agency prefers randomized trials and encourages sponsors to consider toxicity in evaluation designs.
FDA confirms 1,100+ employee hiring surge — The agency’s contract notice confirmed “OMB approval to hire 1,100+ new employees under FY26 FDA Hiring Plan,” with Treasury Department assistance for relocations beginning October 1, 2026, marking first concrete confirmation of Commissioner Makary’s promised hiring expansion.
Mifepristone REMS petition rejected by FDA 💊 — The agency denied antiabortion groups’ petition requesting a strengthened Risk Evaluation and Mitigation Strategies plan, including in-person prescribing requirements, follow-up appointments, ultrasound confirmation requirements, and enhanced adverse event reporting, stating inability to resolve “complex scientific and legal issues” within a 150-day timeframe.
PreCheck pilot accepting applications as of February 1 💊 — The FDA announced a phased rollout of the manufacturing reshoring pilot program: applications accepted February 1, initial reviews begin March 1, finalist selections by April 1, final cohort selection by June 30. The program aims to help companies bring operations back to the United States.
Valneva withdraws chikungunya vaccine application 💊 — The manufacturer voluntarily withdrew its Ixchiq licensing application after the FDA suspended the license last summer and imposed a recent clinical hold, marking a retreat from the U.S. market following safety concerns.
Supreme Court to hear “skinny label” patent case 💊 — The court agreed to review Hikma Pharmaceuticals v. Amarin Pharma, focusing on generic drugmakers’ ability to “carve out” patent-protected claims from generic labels and whether marketing “totality” constitutes infringement even with FDA-approved generic equivalence claims.
Country-of-origin labeling legislation introduced 💊 — Sen. Rick Scott announced the CLEAR LABELS Act, requiring prescription drugs to include country-of-origin information on labels or through a searchable portal, addressing drug supply chain transparency concerns. Senate Aging Committee experts agreed companies shouldn’t claim manufacturing location as trade secret.
FDA removes cellphone safety webpages amid HHS radiation study 💉 — The agency “quietly removed webpages saying cellphones aren’t dangerous” while HHS launches electromagnetic radiation health research study under RFK Jr.’s direction, reversing previous determination that “weight of scientific evidence” didn’t support RF-health problem links.
Compliance and Enforcement
Form 483 response guidance sent to White House 💊 — The FDA transmitted draft guidance “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection” to OIRA for review, aimed at clarifying sponsor responses to manufacturing condition observations following current Good Manufacturing Practice inspections.
RegenxBio gene therapy paused after brain tumor discovery 💊 — The FDA placed clinical holds on RGX-111 and RGX-121 after a brain tumor was found in a Hurler syndrome patient treated with RGX-111 four years ago. Analysis of tumor tissue showed viral vector DNA integration linked to PLAG1 gene overexpression associated with cancer development, though causality not established.
Repeat untitled letter for ARS Pharmaceuticals 💊 — The Office of Prescription Drug Promotion sent a second letter citing misleading Neffy promotions using phrases like “No needles!” and “Goodbye, needle fear,” arguing patients may still need injectable epinephrine post-treatment and device storage/single-use requirements were inadequately communicated.
CBER warns HIV self-collection kit companies 💉 — The Center issued four warning letters to Germaphobix, Genovate, Genetrace, and ProDx Health for selling HIV serological diagnostic dried blood spot self-collection kits without marketing authorization, noting that collection devices constitute medical devices for disease diagnosis.
Hyde-Smith reintroduces mifepristone restrictions bill 💊 — Sen. Cindy Hyde-Smith’s SAVE Moms and Babies Act (S. 3697) calls for the FDA to reimpose in-person prescribing requirements through a strengthened REMS plan, including follow-up appointments, ultrasound confirmation requirements, and enhanced adverse event reporting.
