OTC ADR REPORTING SYSTEM WILL DEPEND ON CONSUMER REPORTING
This article was originally published in The Tan Sheet
Executive Summary
OTC ADR REPORTING SYSTEM WILL DEPEND ON CONSUMER REPORTING, which may require "revised labeling which provides information to consumers on how and where to report [adverse drug reactions] to the manufacturer, packager or distributor," FDA Deputy Chief Counsel for Program Review Ann Wion said at the Food & Drug Law Institute's annual educational conference Dec. 14.