FDA’s Office of Inspections and Investigations: A Look at FDA’s Field Operations Six Months After ORA Became OII

Effective October 1, 2024, FDA’s Office of Regulatory Affairs (ORA) transformed into the new Office of Inspections and Investigations (OII). This second reorganization of field operations within a decade changed the way that companies interact with FDA personnel in the field and the Centers, especially in inspection and compliance situations.  This webinar will provide a recap of the changes and the effects on firms, as well as practical guidance and tips for interacting with FDA during and in the wake of inspections. 

For questions, contact Christine Lieber.