Yesterday, FDA issued two memos of interest to the dietary supplement industry:
The first, a 14-page guidance document, "Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic," is an update to a 2012 guidance and outlines the agency's recommendations regarding postmarketing adverse event reporting when high employee absenteeism at the agency and industry while "reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase."
FDA believes this approach will make it possible for firms with reporting responsibilities to focus their limited resources on the following types of reports:
The second communication is a March 23 update, "Food Safety and the Coronavirus Disease 2019 (COVID-19)" that consists of three elements:
With warm regards,