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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring continued patient-centered regulation in the era of emerging artificial intelligence (AI) and personalized medicine. The plan outlines commitments and steps the agency should take through 2030 to keep pace with rapid technological and scientific developments and bring safe and effective treatments to patients more quickly.

The Medicines and Healthcare products Regulatory Agency (MHRA) says the UK government has adopted a list of recommendations on the use of artificial intelligence (AI) in medical devices developed by an independent group of doctors in the National Health Service (NHS). The agency also said it is initiating the third phase of its AI Airlock, a regulatory sandbox for evaluating new AI products.

The Council of the European Union has adopted new rules for the pharmaceutical sector, advancing efforts to reform legislation governing the industry.

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, Senators grilled President Trump’s nominee to lead FDA during her confirmation hearing, and the agency published a rule to aimed at reducing animal testing.

CHARLOTTE, NC — Regulators and industry experts stressed the need for regulatory harmonization around artificial intelligence (AI) to ensure the technology is used responsibly in drug development during a panel discussion at RAPS Convergence 2026.

CHARLOTTE, NC — When former US Food and Drug Administration (FDA) Commissioner Robert Califf was a medical student in the mid-1970s, he had an opportunity to work with his mentor on one of the first patient databases. Patients undergoing cardiovascular procedures would have their data captured as a part of clinical care and were followed for life.

The US Food and Drug Administration (FDA) has announced the permanent appointment of four top officials to lead the agency's drug, biologics, and tobacco centers, as well as a deputy commissioner for technology and artificial intelligence. The three product center directors were previously serving in those roles in an acting capacity.

Sponsors who want to use digitally derived endpoints from digital health technologies (DHT) should validate those endpoints for the intended patient population, pre-specify their missing-data strategy at every level of their clinical trial, and avoid conflating device clearance with endpoint validation, according to US Food and Drug Administration (FDA) officials who spoke at a recent public meeting.

The US Food and Drug Administration (FDA) is seeking feedback on a competency-based approach to regulating medical devices that utilize generative artificial intelligence (GenAI).

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