Comment Period Extended for Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products

December 12, 2016

The FDA extended the comment period for a public meeting related to a draft guidance on the development of generic abuse-deterrent opioid pain medications.

At the meeting, representatives from the generics industry suggested that the draft guidance, issued in March, be revised and reissued for another round of public comments. The FDA has approved seven branded abuse-deterrent opioids, but there are currently no approved generics.

The comment period has been extended to Jan. 3, 2017. The FDA requested input on the agency’s efforts to develop standardized in vitro testing methodologies for evaluating the products abuse-deterrent properties.

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