Wednesday, February 6, 2019

FDA in Brief: FDA finalizes new policy to encourage widespread innovation and development of new buprenorphine treatments for opioid use disorder

Today, the U.S. Food and Drug Administration 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.

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