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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, we learned that the White House’s nominee to lead FDA won’t get a confirmation vote until after the US November mid-term elections, that FDA seems to be restrengthening its advisory committee system, and more.

Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug Administration (FDA) Center for Devices and Radiological Health for fiscal year (FY) 2027, the center announced on 1 October. CDRH plans to publish 11 final guidance documents and three draft guidance documents this fiscal year.

The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program. The program aims to transform how clinical trials are designed and conducted to streamline them and ultimately bring products to market sooner.

The International Coalition of Medicines Regulatory Authorities (ICMRA) issued a joint statement encouraging manufacturers and national control laboratories to reduce animal testing throughout the lifecycle of medicines. ICMRA also encouraged regulators to challenge any proposals that suggest using animals for batch release testing.

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

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Most companies treat the Form 483 response as the chance to close the loop after an FDA inspection. In many warning letters, FDA reaches a different conclusion: the company responded, FDA reviewed the response, and the agency still found the answer incomplete.

The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the committees saw a diminished role under previous FDA leadership.

Industry groups and other stakeholders are generally supportive of FDA’s recent draft guidance explaining when single pivotal trials plus confirmatory evidence can be used to support the approval of drugs and biologics; however, the commenters were split over how flexible the agency should be in its approach and asked for additional clarity