Droice Labs had the opportunity to submit a letter to the FDA on their draft guidance titled Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (referred to as “Draft Guidance”). The Draft Guidance recognizes the importance of utilizing real-world data (RWD) for external control arms (ECA) and lays… Continue reading Droice comments to the FDA on recent draft guidance on external control arms
