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          General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry
					
		
		November 2017


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    PrintDocket Number:
		    FDA-2016-D-0785
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance is intended to assist a person who plans to develop and submit an abbreviated new drug application (ANDA) (hereinafter potential ANDA applicant) to seek approval of a generic version of a solid oral opioid drug product that references an opioid drug product with abuse-deterrent properties described in its labeling. The guidance recommends studies, including comparative in vitro and pharmacokinetic (PK) studies, that the potential ANDA applicant should conduct and submit to FDA in an ANDA to demonstrate that a generic solid oral opioid drug product is no less abuse deterrent than its reference listed drug (RLD) with respect to all potential routes of abuse.


 
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						All written comments should be identified with this document's docket number: FDA-2016-D-0785.

                                                                                  Content current as of:
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