Agency issues draft guidance for abuse-deterrent generics
Silver Spring, Maryland–(ENEWSPF)–March 24, 2016. The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic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…
