In September 2021, the US Food and Drug Administration (FDA) published the first update to its Bioresearch Monitoring Compliance Program Manual for Sponsors and Contract Research Organizations since 2017. This document, which serves as FDA’s Standard Operating Procedure for conducting a GCP inspection, is a critical resource for sponsors and CROs preparing for inspections. Other than the switch from serif to sans serif, what’s new? Download our exclusive synopsis to find out.