RA/QA News Roll: Mid November 2025
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
Pazdur accepts CDER director role after extended negotiations — Rick Pazdur, longtime director of the Oncology Center of Excellence, officially accepted the position of CDER director following intensive weekend discussions with Commissioner Makary. Multiple outlets reported that Makary spent considerable time persuading Pazdur to take the job, offering assurances of autonomy and the ability to rehire certain staff. Pazdur will retain his OCE directorship while leading CDER, adding to his expanding portfolio of responsibilities.
Prasad and Pazdur acknowledge tensions between CBER and OCE 💊 — In the most recent “FDA Direct” episode, CBER Director Vinay Prasad and newly appointed CDER Director Rick Pazdur openly discussed historical friction between their centers. “People may not know, but Rick and I have been working hand-in-glove for the last few months,” Prasad explained, adding that previously “there wasn’t always alignment” between CBER and OCE. Commissioner Makary noted the understatement, remarking “there’s been sort of infighting here, you know, territorial tribal lines, gerrymandering of what goes in what center and what goes in oncology.” Prasad joked the situation resembled “medieval Europe. A lot of warring clans. And now the Roman Empire is coming.”
Hiring freeze creates center-to-center staff poaching problems 💊 — Email exchanges obtained by STAT News revealed significant tensions over staff recruitment between CBER and CDER leadership. Prasad wrote to CDER Deputy Director Mike Davis: “If you continue to choose not to do what I tell you, I will spend all of my political capital gets [sic] you fired. Do not take people from my team.” The conflict stems from the agency being largely prohibited from hiring external candidates, forcing centers to rely on internal transfers and creating competition for talent. Sources indicate this dynamic is worsening as attrition continues across the agency.
Makary defends media coverage amid leadership turmoil — FDA Commissioner Makary posted on social media, alleging that prior reporting on who would become CDER director had been “misleading,” posting headlines showing Pazdur initially declining the role, contrasted with later reports confirming his acceptance. However, Endpoints reported that Makary spent considerable time last weekend convincing Pazdur to accept, undermining claims of misleading coverage.
Makary cancels WSJ appearance, maintains other speaking commitments — Commissioner Makary canceled his scheduled appearance at the Wall Street Journal’s Future of Health event this week without explanation. However, he was confirmed to speak at the Milken Institute’s annual Future of Health Summit alongside CMS Administrator Mehmet Oz in a session moderated by Esther Krofah.
FDA General
New innovation hubs proposed for cardiology and nephrology 💊 — In a recent “FDA Direct” episode, CBER Director Prasad expressed enthusiasm for Pazdur’s proposal to create Center of Excellence-like structures coordinating CBER and CDER actions in disease areas including cardiology, nephrology, and rare diseases. The concept would mirror the existing Rare Disease Innovation Hub led by Amy Comstock Rick. Prasad said the goal is consistency in how FDA reviewers treat diseases regardless of center—a point frequently raised by drug company executives during Makary’s CEO listening sessions.
First National Priority Voucher review completed 💊 — Commissioner Makary revealed in “FDA Direct” that the FDA has completed its first review under the Commissioner’s National Priority Voucher program. “The first review I thought went beautifully,” Makary said, adding it demonstrates program feasibility. Notably, Makary called the review process a “minimal viable product”—suggesting improvements are forthcoming as the agency gains more experience with the program.
Real-world evidence guidance in development 💊 — Commissioner Makary indicated the FDA is working on an updated approach to accepting real-world data and evidence. “Can we ask ourselves: What should the requirements of real-world data be, and can we let the companies know this is what we’d like to see,” Makary explained. “Hopefully in the coming months, we’ll have some good announcements.” The comments suggest new guidance could provide clearer parameters for real-world data submissions.
Bayesian methodologies guidance cleared by White House 💊 — The White House approved an important FDA draft guidance focused on using Bayesian methodologies in clinical trials of drug and biological products. Bayesian methods involve advanced statistical approaches useful for trials that accumulate evidence over time. The guidance could support Commissioner Makary’s emerging proposals promoting “continuous” and “seamless” clinical trials. Publication is expected soon.
Final guidance issued on pH adjuster waivers 💊 — The FDA released a new final guidance on considerations for sponsors making waiver requests for pH adjusters in products intended for parenteral, ophthalmic, or otic use. The guidance addresses how companies should operate within special regulatory restrictions related to inactive ingredient sameness. The final version follows an April 2022 draft.
GDUFA VII negotiations underway with experienced teams 💊 — The FDA posted meeting minutes from the first round of Generic Drug User Fee Act reauthorization negotiations, revealing the complete roster of participants. The agency fields 19 participants including experienced negotiators Rob Lionberger, Ashley Boam, Angela Granum, Susan Rosencrance, Kristin Davis, Kendra Stewart, and Malik Imam. Industry representation includes the Association for Accessible Medicines (Giuseppe Randazzo and Scott Kuzner), Pharmaceutical and Biopharmaceutical Outsourcing Association (Gil Roth), and Bulk Pharmaceutical Task Force (Joel Carpenter), along with representatives from Catalent, Amneal, Apotex, Teva, and Sandoz.
Paper-based prescribing information mandate remains 💊 — Section 722 of the FDA funding bill signed into law continues prohibiting FDA funds from being used to allow or require electronic distribution of prescribing information to healthcare professionals “in lieu of in paper form” unless Congress passes specific authorizing legislation. Critics including the Alliance to Modernize Prescribing Information argue the ban results in outdated medical information and waste of 90 billion pages annually, while supporters emphasize ensuring ready availability of prescription information.
UniQure faces FDA reversal on Huntington’s gene therapy 💊 — UniQure announced the FDA reversed course and would no longer consider data from a Phase I/II trial sufficient to support approval of its Huntington’s disease gene therapy, AMT-130. “uniQure believes that the FDA currently no longer agrees that data from the Phase I/II studies of AMT-130 in comparison to an external control may be adequate to provide the primary evidence in support of a BLA submission,” the company explained. This represents a significant shift from prior communications in multiple Type B meetings over the past year. The company had announced alignment with FDA in June—shortly before gene therapy division leaders Nicole Verdun and Rachael Anatol were ousted from their roles. New leadership under Vijay Kumar may have different interpretations of necessary clinical evidence.
UCB receives rare pediatric disease voucher 💊 — UCB announced FDA approval of Kygevvi (doxecitine and doxribtimine), the first treatment for adults and children living with thymidine kinase 2 deficiency. The approval included a valuable Rare Pediatric Disease Priority Review Voucher, adding to the list of recent voucher awards.
New drug-induced liver injury biomarker qualified 💊 — The FDA qualified a new biomarker for detecting drug-induced liver injury, expanding the agency’s toolkit for safety assessments during drug development.
CBER updates tracking number procedures 💊 — CBER published an updated Standard Operating Procedure (SOPP 8117) focused on issuing tracking numbers in advance of electronic submissions in the Electronic Common Technical Document format. First published in September 2007, the latest version includes important updates regarding pre-assignment timing, pre-submission types (such as INTERACT meetings), and differentiation for different types of clinical trial applications.