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CRE's Regulatory Action
of the Week

FDA Extends Comment Period on Opioid Drug Products Meeting
The U.S. Food and Drug Administration has extended the comment period for the public meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products that was announced in the Federal Register on October 6, 2016. In that Federal Register notice, FDA requested comments on the approach to testing FDA recommended in its draft guidance "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products" and on FDA's efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. In response to requests for an extension, FDA is extending the comment period to January 3, 2017.

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