Posted by Michael Wonder on 02 Jun 2023
FDA considers new efficacy endpoint for diabetes drugs
31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for new anti-diabetic drugs and biologics for adults and children with type 1 and type 2 diabetes.
The draft guidance replaces a previous version issued in 2008 guidance, which was withdrawn in 2020 because its safety recommendations were outdated. Endpoints related to clinical complications or preventing type 1 diabetes and issues related to statistical analysis are outside the scope of the guidance.
