Roche and Eli Lilly are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval.
Tag Archive for: validation
In December 2021, the FDA issued draft guidance to lifescience researchers on evaluating EHR and claims data in studies to support regulatory decisions. This new draft guidance covers using real-world data from these sources to support regulatory decisions on both safety and effectiveness.
