The US Food and Drug Administration (FDA) has updated its operating framework for evaluating and inspecting human drug manufacturing facilities. The revised Concept of Operations (ConOps), dated 21 October 2026, formalises the use of remote regulatory assessments and inspection information from international regulatory partners, while clarifying how the agency's drug review and inspection teams coordinate their work. FDA's framework for GMP inspections and facility evaluation The FDA's updated document, Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations, describes how the Center for Drug Evaluation...