FDA Requests Comments on Substantial Proposed Changes to Data Standards

FDA Requests Comments on Substantial Proposed Changes to Data Standards

Advances in data management and in the use of novel data sources in clinical research have cast a spotlight on the data standards FDA requires for study data submitted in marketing applications. These data standards, compiled in an FDA spreadsheet known as the Data Standards Catalog, have changed little over the past several years despite increasing focus by FDA and the clinical research community on new sources of data, such as real-world data …