We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Takes Aim at Branded Drugmakers’ Delaying Tactics on Shared REMS
FDA Takes Aim at Branded Drugmakers’ Delaying Tactics on Shared REMS
The FDA is working to prevent manufacturers of branded high-risk drugs from stalling an application for approval of a generic competitor via manipulation of a requirement to share safety programs, Commissioner Scott Gottlieb said.