CDRH advertising and promotion tracking system
This article was originally published in The Gray Sheet
Executive Summary
FDA's device center is in the early stages of developing an internal system for tracking device firms that have violated advertising and promotion rules, which will be similar to the drug center's existing system, according to CDRH regulatory council Ann Simoneau. The device center "only gets a fraction of the trade complaints" that the drug center gets, Simoneau notes