Aetion Submits Comments on FDA’s Draft Guidance Electronic Health Records and Regulatory Decision-Making

February 4, 2022

Aetion submitted its comments to the FDA on their recent draft guidance regarding the use of real-world data to support regulatory decision-making. The draft guidance signals a shift towards greater use of real-world data by enhancing mutual understanding of department expectations and by setting established guiding principles and best practices. Aetion’s comments focused on the attention to detail needed in implementing the guidance and the pre-defined essential elements in study design.

According to Aetion, “While a software platform can address many of the Draft Guidance’s recommendations, there are some aspects that are dependent on information from the data source, and we encourage FDA to provide recommendations to help sponsors and analytics providers evaluate the level of available information when deciding whether to use a commercially available dataset in a study.”