Imprese · 05/12/20161 min di lettura
Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products; Extension of Comment Period
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Riepilogo
The Food and Drug Administration (FDA or we) is extending 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 In that Federal Register notice, FDA requested comments on the approach to testing FDA recommended in its draft guidance "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products" and FDA's efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.