On May 18, 2018 the FDA issued the final version for the Guidance for Industry Bioanalytical Method Validation. What has been incorporated into the Guidance is a new tabular presentation of validation parameters for chromatography and ligand binding assays. The guidance also presents FDA expectations on biomarker assays used during drug development, and updates various bioanalytical practices based on the proceedings of the 2013 AAPS/FDA Collaboration meeting, Crystal City V.
The purpose of the workshop is highlight the new elements of the Guidance and provide a space for regulators to respond to audience questions using an open forum and panel discussion format.