FDA Releases Final AER Guidance

WASHINGTON— FDA released the final guidance regarding recordkeeping and reporting of adverse events for dietary supplements. Originally released in 2007, the updated guidance incorporated comments from industry and other interested parties, and is designed in a Q&A format. Among the topics addressed are what FDA defines as a “serious adverse event,” the timing for submitting adverse event reports (AERs), and the minimum information that should be included in the AER.