PSM writes to support changes to FDA's Medwatch reporting system

On June 26, PSM submitted comment to support proposed revisions to forms FDA 3500 and FDA 3500B, which are used to report adverse events, product use/medication errors, product quality problems, and therapeutic failures from prescription and over-the-counter medicines that ultimately appear in the FDA's Adverse Event Reporting System (FAERS).

PSM particularly supports the FDA's intention to add questions about where and when a reporter acquired product(s) involved in an adverse event, which would add greater insight to health policy researchers.

Read our submission here.