Electronic reports guidance
This article was originally published in The Tan Sheet
Executive Summary
"Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports" draft guidance issued in May 4 Federal Register. Individual case safety reports may be submitted through FDA's Electronic Data Interchange or on a physical medium; ICSR attachments must be submitted on a physical medium in Adobe Acrobat format, draft says. Comments will be accepted for 60 days