Gottlieb: FDA To Publish 150 REMS Letters Sent To Brand Makers 'As Early As Thursday'

May 14, 2018
FDA is expected to, as early as Thursday (May 17), unveil a new web page on which it will initially publish 150 letters sent by the agency to brand companies explaining that a potential generic competitor has adequate safety protections in place to receive the brand drug samples for bioequivalence testing, FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar announced Monday (May 14). Gottlieb told reporters this marks the first time the agency will make such letters public, coming...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on the coming Democrat-controlled House of Representatives, drug pricing reforms, Medicaid policy, FDA news and much more.