FDAnews
www.fdanews.com/articles/146093-big-or-small-fda-wants-to-hear-about-all-trial-related-aes

Big or Small, FDA Wants to Hear About All Trial-Related AEs

May 3, 2012
Trial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to an agency guidance. The agency supports the additional reporting even though it runs counter to regulations. Currently, only DMC recommendations on serious adverse events (SAE) must be reported to the FDA, the April 20 guidance notes. The Office of Management and Budget is reviewing the guidance now under the Paperwork Reduction Act, and it should be published within the next few months if approved.
Devices & Diagnostics Letter