The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have agreed on terms of reference for a cardiovascular cluster, aiming to share scientific evaluations of drug development for cardiovascular diseases. The cluster, established under a document dated 17 July 2026, will facilitate regular teleconferences and ad-hoc exchanges to align regulatory approaches, discuss trial endpoints, safety populations, statistical methods, and post-marketing issues. Participants include EMA staff from the Office for Therapies for Endocrine and Cardiovascular Diseases and the Scientific Advice office, and FDA staff from the Division of Cardiovascular and Nephrology. Health Canada and Swissmedic are permanent observers, and other regulatory authorities may join with mutual agreement and confidentiality arrangements. Teleconferences are anticipated quarterly, each lasting about one hour, with ad-hoc meetings for pressing product-related assessments. The EMA and FDA will share agenda-setting responsibilities, selecting topics of shared interest. No prior coverage of this cluster exists in the last 180 days.
Source📄 Open document ↗