FDA Finalizes Buprenorphine Guide To Spur Development, Coverage

By Beth Wang
February 6, 2019 at 12:14 PM
FDA on Wednesday (Feb. 6) finalized guidance detailing the types of clinical studies and novel endpoints that can be used to support approval of depot buprenorphine products and how sponsors should design efficacy trials. The guidance is part of the agency’s efforts to encourage widespread use and coverage of FDA-approved medication-assisted treatment (MAT), agency head Scott Gottlieb said in a press statement on Wednesday. On Wednesday, Gottlieb stressed an urgent need for better treatment options for opioid use disorder (OUD)...

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.