When in Brussels (or Bern, or London): FDA’s ConOps 2.0 and the Significance of MRA Inspections November 12, 2026 By Kalie E. Richardson —

https://www.thefdalawblog.com/2026/11/when-in-brussels-or-bern-or-london-fdas-conops-2-0-and-the-significance-of-mra-inspections/?utm_source=rss&utm_medium=rss&utm_campaign=when-in-brussels-or-bern-or-london-fdas-conops-2-0-and-the-significance-of-mra-inspections Back in June 2017, CDER and the Office of Regulatory Affairs (ORA) signed a “Concept of Operations” (ConOps) white paper laying out how the two would divide responsibility for drug facility evaluations and inspections. Nearly a decade, one major reorganization, and a lot of remote-assessment experimentation later, the Agency has published an update. The new ConOps 2.0, effective October 21, 2026, comes from CDER and the Office of Inspections and Investigations (OII), as ORA is now known.