Abuse-Deterrence Among New GDUFA Regulatory Science Priorities

FDA says it will need tools to evaluate technologies designed to deter nasal abuse in generics.

Among FDA’s generic drug research priorities for this fiscal year will be ways to review potential abuse-deterrent formulations specifically targeting the nasal route.

It is a particularly timely focus for the agency as it continues pushing for scientific advances in the area and responds to critics about its handling of opioid products with...

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