Posted by Michael Wonder on 06 Feb 2019
FDA finalises new policy to encourage widespread innovation and development of new buprenorphine treatments for opioid use disorder
6 February 2019 - Today, the U.S. FDA issued a final guidance, “Opioid Use Disorder: Developing Buprenorphine Depot Products for Treatment,” which outlines the FDA’s current thinking about drug development and trial design issues relevant to the study of buprenorphine depot products, such as modified-release products for injection or implantation.
The guidance includes minor changes to the draft document published in April 2018.
