Federal Register Notice: FDA is a making a draft guidance available for industry, Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting — Improving Human Subject Protection. It is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to institutional review boards (IRBs). FDA developed the guidance due to concerns raised by the IRB community that increasingly large volumes of individual adverse event reports are inhibiting rather than enhancing IRBs' ability to adequately protect human subjects. To download this guidance, click here. To view this notice, click here.