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          Abuse-Deterrent Opioids-Evaluation and LabelingSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Abuse-Deterrent Opioids-Evaluation and Labeling
					
		
		April 2015


	Download the  Final Guidance Document 

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

                                                                                  Content current as of:
      02/17/2022
         
                  
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