News & Insights Search

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Industry groups and other stakeholders are generally supportive of FDA’s recent draft guidance explaining when single pivotal trials plus confirmatory evidence can be used to support the approval of drugs and biologics; however, the commenters were split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

The US Food and Drug Administration (FDA) published a draft guidance detailing its thinking on the requirements for bringing certain robotically assisted surgical devices (RASD) to market. It includes non-clinical and clinical testing requirements that sponsors should include in their premarket submissions.

CHARLOTTE, NC – A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help sponsors bring products to market more streamlined and predictably.