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New Draft Guidance on Opioid Use Disorder Treatment Approval

The Food and Drug Administration (FDA) on Aug. 6 released draft guidance on new potential ways to measure the efficacy and benefit of medication-assisted treatment (MAT) for opioid use disorder (OUD).

Prior FDA approval of new drugs for MAT was based on research showing their efficacy primarily in decreasing use of opioids. The new guidance encourages researchers to look at a broader set of outcomes, including a reduction in relapse overdoses and rates of disease transmissions.

The guidance aims to encourage the development of MAT drugs tailored to patient needs and give more options to individuals with OUD.

FDA is accepting comments on the draft guidance through Oct. 9.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Rachel Schwartz is a former policy associate at America's Essential Hospitals.

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