Psychiatric Adverse Events: Navigating a New Drug Safety Landmine
This article was originally published in RPM Report
Executive Summary
Psychiatric drug safety isn't just about antidepressants any more. An increased risk of depression and suicidality is killing new drug prospects and has threatened multi-billion dollar franchises. FDA aims to help by injecting some clarity and predictability into the process. Now It's up to sponsors to take advantage of ithe FDA's initiatives.