Federal Register Notice: FDA is making available a Study Data Technical Conformance Guide, Version 2.0, and an update to the Data Standards Catalog. The guide supplements the final guidance for industry entitled Providing Regulatory Submissions in Electronic Format — Standardized Study Data and provides specifications and recommendations for, as well as general considerations on, submitting standardized study data using FDA-supported data standards specified in the catalog. The guide is intended to complement and promote interactions between sponsors and FDA review divisions. To view this notice, click here.