April 25, 2022
FDA Issues ICH E8 Revision
On April 8, 2022, the U.S. Food and Drug Administration (FDA) adopted and issued the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E8(R1) General Considerations for Clinical Studies. ICH E8 guidelines sets out general scientific principles for the conduct, performance, and control of clinical trials, and addresses a wide range of topics in trial design and execution. This revision is the first major revision since 1997 and marks the initial step in the ICH’s Good Clinical Practice Renovation project and will continue with the revision of E6(R2) guidelines on Good Clinical Practice (GCP).