The Food and Drug Administration (FDA) has published an updated version of “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations” (ConOps). The ConOps is the agreement between the Center for Drug Evaluation and Research (CDER) and the Office of Inspections and Investigations (OII) that sets out how the two agency components coordinate marketing application assessments, inspections and related compliance activities. It applies to preapproval, postapproval, surveillance and for-cause inspections of human drugs. “ConOps 2.0” took effect on October 21, 2026, and replaces the original June 2017 version. While its title sounds technical, for products regulated by CDER, it provides valuable background into how inspection and compliance related activities are managed within the agency.