Regulatory Focus

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’re looking at some of the ways the midterm election results could impact FDA over the next two years, starting with the confirmation prospects for President Trump’s pick for FDA commissioner and how Democrats may use their newfound oversight powers.

BARCELONA – Experts called for a more streamlined framework for artificial intelligence (AI) for healthcare products in Europe and urged regulatory professionals to increase their AI literacy, while cautioning against overreliance on the technology, during a panel discussion at the RAPS AI in Regulatory Conference.

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.