FDA foreign inspections ORA

Role of FDA’s Office of Regulatory Affairs (ORA)

June 3, 2025 digi

Role of FDA’s Office of Regulatory Affairs (ORA) Understanding the Role of the FDA’s Office of Regulatory Affairs (ORA) in GMP Oversight The Office of Regulatory Affairs (ORA) is the field operations arm of the US Food and Drug Administration (FDA), responsible for conducting inspections, enforcing compliance, and protecting public health through regulatory oversight. In…

International GMP Inspection Standards and Harmonization, US FDA GMP Inspection Programs