FDA Updates Drug Facility Inspection Program with ConOps 2.0, Integrating Remote Assessments and AI
The U.S. Food and Drug Administration (FDA) has released an updated concept of operations, ConOps 2.0, for its drug facility evaluation and inspection program, effective October 21, 2026. This update replaces the 2017 version and outlines how the Center for Drug Evaluation and Research (CDER) and the Office of Inspections and Investigations (OII) coordinate marketing application assessments, inspections, and compliance activities. A significant change is the integration of remote regulatory assessments, including section 704(a)(4) records requests and remote interactive evaluations like livestreamed walkthroughs, across all four inspection types. ConOps 2.0 also clarifies how FDA incorporates inspection reports from mutual recognition agreement (MRA) partners in the EU, UK, and Switzerland into its workflows, allowing these reports to support application decisions and fulfill routine surveillance requirements. Additionally, the updated document introduces a specific deadline for preapproval inspection clas...
