Regulatory Focus

BETHESDA, MD – A top US Food and Drug Administration (FDA) official stated that the midterm congressional election results will not likely impact the reauthorization of the agency’s user fee agreements, which have been negotiated for FY 2028-2032.

The Medical Device Coordination Group (MDCG) has published guidance on how clinical evidence requirements apply to orphan in vitro diagnostics (IVDs).

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

BARCELONA – As artificial intelligence (AI) permeates the regulatory world, experts said it won't take over regulatory professionals' jobs but will instead help them work more efficiently and dedicate more time on human interactions. However, they said it is the responsibility of regulatory professionals to understand the technology's capabilities and limitations, as well as their ability to use it effectively.

BETHESDA, MD – Sarah Yim, director of the US Food and Drug Administration’s (FDA) Office of Therapeutic Biologics and Biosimilars in the Office of New Drugs, emphasized that the agency is actively working to help sponsors reduce their reliance on clinical efficacy studies to demonstrate that a new biosimilar is comparable to its reference drug and to build public confidence in biosimilars.

BETHESDA, MD – A top US Food and Drug Administration (FDA) enforcement official announced that the agency conducted more unannounced drug inspections in India and China in FY 2026 compared to the previous year.

More than 500 comments have been submitted in response to the US Food and Drug Administration’s (FDA) discussion paper on generative AI (genAI)-enabled medical devices, and stakeholders have offered the agency a wide variety of advice on the best way to regulate these technologies.

BARCELONA – Navigating Europe’s complex environmental and sustainability legislation can be daunting, but healthcare product manufacturers can take concrete steps to ensure they remain compliant, according to two legal experts who spoke at RAPS Regulatory Intelligence Conference Europe on Tuesday.