FDA Releases Draft Guidance on Bayesian Methodology in Clinical Trials – What It Means for Innovative Study Designs
FDA releases draft guidance on Bayesian methods in clinical trials. Learn how device manufacturers can benefit from this innovative approach.
FDA publishes new M11 technical specification for electronic harmonized clinical protocols (CeSHarP)
The FDA's new M11 technical specification, developed within the framework of ICH, defines a structured and harmonized electronic template for clinical protocols - CeSHarP. This document promotes the international standardization of clinical trial documentation, facilitating electronic submission and regulatory interoperability between agencies such as the FDA, EMA and PMDA.