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.

As a reminder, the ConOps is an internal operating model, not guidance, and it does not create new obligations for industry. But it is the closest thing we have to a road map of who will evaluate your facility, with what tools, and who gets the final say on your inspection classification. Like the original, version 2.0 does not apply to pharmacy compounding or bioresearch monitoring assessments. Much of the update formalizes practices FDA has been rolling out piecemeal, including the alternative tools...[FDABlog]