Federal Register Notice: FDA is making available a guidance for industry: Providing Regulatory Submissions in Electronic Format — Standardized Study Data. It describes how the agency plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions under NDAs, ANDAs, BLAs, and INDs. It finalizes the revised draft guidance that was issued 2/6. To download this guidance, click here. To view this notice, click here.