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          Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
					Guidance for Industry
		
		April 2020


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    PrintDocket Number:
		    FDA-2018-D-3380
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health
          Center for Drug Evaluation and Research
          Oncology Center of Excellence


This guidance describes considerations for the development and labeling of *in vitro* companion diagnostic devices (referred to as “companion diagnostics” herein) to support the indicated uses of multiple drug or biological oncology products, when appropriate. This guidance builds upon existing policy regarding the labeling of companion diagnostics. In a prior guidance issued in 2014, the Agency stated that if evidence is sufficient to conclude that the companion diagnostic is appropriate for use with a specific group of therapeutic products, the companion diagnostic’s intended use/indications for use should name the specific group of therapeutic products, rather than specific products. This guidance expands on the policy statement in the 2014 guidance by recommending that companion diagnostic developers consider a number of factors, including but not limited to those discussed in this guidance, when determining whether their test could be developed, or the labeling for approved companion diagnostics could be revised through a supplement, to support a broader labeling claim such as use with a specific group of oncology therapeutic products (rather than listing an individual therapeutic product(s)).


 
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						All written comments should be identified with this document's docket number: FDA-2018-D-3380.

                                                                                  Content current as of:
      04/13/2020
         
                  
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