Request for Global Harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis

"the industry has expressed their concerns that multiple regulations on a similar topic will not benefit data generated in bioanalytical laboratories worldwide." The 2001 US FDA Bioanalytical Method Validation (BMV) guidance document has been widely accepted and adopted by the bioanalytical community worldwide. As such, it has become the cornerstone of regulated bioanalytical laboratory procedure. In recent years, clarifications to these FDA guidelines and subsequent enhancements were discussed at North American- and European-hosted meetings and conferences. The outcome of these meetings, published in White Papers, conference reports or recommendations, are currently being implemented in many bioanalytical laboratories around the world....