AERs for OTCs
This article was originally published in The Tan Sheet
Executive Summary
FDA is "trying to propose a rule for OTC products with FDA reporting requirements," Office of Drug Safety Division of Drug Risk Evaluation Associate Director Min Chen said at a DIA Pharmacovigilance meeting in Washington, D.C. Jan. 24. The goal is to plug the "big hole in the safety reporting game" caused by monograph OTC drugs, Chen explained. Initial development of funding is coming from some of last year's funds, she said. "Congress is behind us as far as OTC products and dietary supplements, and hopefully, this will be next year, we'll have some updates in this area"...