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GUIDANCE DOCUMENT

Abuse-Deterrent Opioids-Evaluation and Labeling April 2015

Download the Final Guidance Document
Final
Docket Number:
FDA-2013-D-0045
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance explains FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. The guidance makes recommendations about how those studies should be performed and evaluated and discusses how to describe those studies and their implications in product labeling.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0045.

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