The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. Today’s actions are among a number of steps the agency recently outlined in an action plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
For more information, please visit: abuse- deterrent opioids.
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