Today’s issue of WorkCompRecap features the release of a new draft guidance document from the FDA aimed at aiding the development of new formulations of opioid drugs with abuse-deterrent properties. The FDA noted that they are extremely concerned about the inappropriate use of prescription opioids, as it has become a “major public health challenge”.
The new document explains the FDA’s current thinking about studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results.
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