This Week at FDA: QMSR and PreCheck kickoff, Makary tries to ease CNPV concerns, and more

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week FDA’s new quality management system requirements took effect, FDA’s PreCheck program opened for submissions, and an internal meeting was held to ease concerns about the Commissioner’s National Priority Voucher program.

After years of preparation, FDA transitioned from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), which better harmonizes with global standards and regulators. As part of the transition, the agency published a couple of revised final guidances that affirm the transition to the new regulation, including a guidance on computer software assurance for production and quality management system software.

FDA launched its Precheck pilot program last weekend, which it said will strengthen the domestic pharmaceutical supply chain. The program is intended to provide participants with greater regulatory predictability, support the construction of domestic manufacturing sites, and streamline manufacturing facility assessments.

STAT News reported that FDA Commissioner Marty Makary and other top agency officials tried to quell concerns from staff about the Commissioner's National Priority Voucher (CNPV) program during an employee town hall meeting. While the program is intended to speed drugs to market that are considered a national priority, staff and former officials have raised concerns that it may not apply sufficient regulatory oversight.

The White House has launched TrumpRx.gov, which the government said will help consumers find discounted brand-name drugs if they pay with cash instead of involving their health insurer. The site lists 43 drugs from AstraZeneca, Eli Lilly, EMD Serono, Novo Nordisk, and Pfizer that signed a most-favored nation (MFN) deal with the Trump administration. Former Pink Sheet reporter and current research director at Public Citizen’s Access to Medicines Program, Sarah Karlin-Smith, noted that 20 of the drugs on the list have generic competition, and consumers may be able to find cheaper versions through insurance or cash-pay services.

After announcing last year that it was encouraging food producers to phase out artificial petroleum-based colors from their products, FDA said this week it would exercise enforcement discretion to allow producers to claim products have “no artificial colors” if they contain natural food dyes instead of artificial ones. The agency simultaneously approved beetroot red as a new food dye and expanded the use of spirulina extract.

Bloomberg News reported that the Health and Human Services (HHS) Office of Inspector General (OIG) is investigating whether Samuel Doran, FDA's deputy chief of staff, divorced his wife to mislead the federal government and avoid conflict-of-interest rules. The couple divorced last year, and his ex-wife is a general partner at a venture capital firm that invests in some health-related startups.

BioSpace reported that the latest spending package signed into law includes provisions to reauthorize FDA's rare pediatric disease priority review voucher program. The program began in 2012 and gave companies a voucher to expedite future drug reviews if they had successfully received approval for a rare disease drug.

FDA, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada, will co-host a three-day hybrid meeting in Ottawa, Canada, starting on 2 June to discuss regulatory perspectives in good clinical practice, bioequivalence and good pharmacovigilance practice. The meeting will bring together a wide array of stakeholders, including regulators, industry representatives, academics and patient advocates.

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) published their net hiring data for the first quarter of FY 2026. CDER noted that it lost 65 staff in the first quarter, after losing more than 1,000 staff in FY 2025, and CBER stated that it lost 27 staff in the first quarter, after losing 224 staff in FY 2025. CDER began the fiscal year with just under 5,000 onboarded employees, compared to just over 6,000 at the start of FY 2025.

Drugs & biologics

STAT News reported details of a complete response letter (CRL) that Corcept Therapeutics received from FDA for its drug relacorilant. The agency said it rejected the drug intended to treat Cushing's disease because it had concerns about its clinical development program and because it was associated with drug-induced liver injury.

Reuters reported that after FDA Commissioner Marty Makary said that the agency would take action against companies that mass-market 'illegal copycat drugs' by claiming they are similar to FDA-approved products last week, online telehealth company Hims and Hers Health's stocks took a tumble. Among its drugs, the company markets a compounded version of Novo Nordisk's diabetes and weight-loss drug Wegovy.

MedPage Today reported that Amgen has rejected FDA's call to withdraw its drug avacopan (Tavneos), intended to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The agency expressed concern about the pivotal trial used to approve the drug and the potential for hepatoxicity, but the company dismissed those concerns.

FDA also published a draft version of the International Council for Harmonisation (ICH) E22 guideline on considerations for patient preference studies. The document is intended to detail the use, design, conduct, analysis, and submission of patient preference studies (PPS).

FDA issued a safety communication that it had updated the labeling for Genentech's Xeloda (capecitabine) and 5-FU (fluorouracil), which is sold by several manufacturers. The agency said the update for the cancer drugs was related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency.

Medtech

Abbott Diabetes Care has issued a class I recall for certain Freestyle Libre 3 and Freestyle Libre 3 Plus continuous glucose meter (CGM) sensors due to concerns that they may be outputting blood glucose readings that are lower than the user's actual readings. The company said it has reported 860 serious injuries and seven deaths associated with the malfunctioning sensors. The news comes at the same time that FDA issued a warning letter to Abbott for failing to meet current good manufacturing practices, including ensuring that its third-party manufacturer was producing the CGMs to specifications.

FDA will host a town hall meeting on 18 February to discuss its recently published final guidance on using real-world evidence (RWE) for regulatory decision-making. The guidance details how regulators determine whether real-world data (RWD) is of sufficient quality to support medical device regulatory decisions.

This Week at FDA: QMSR and PreCheck kickoff, Makary tries to ease CNPV concerns, and more

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