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 In this section:

        Drug Development Tool (DDT) Qualification Programs

Clinical Outcome Assessment (COA) Qualification Program

                        
                Clinical Outcome Assessment (COA) Qualification Program: Frequently Asked Questions
          Clinical Outcome Assessments  (COA) Qualification Program Resources
          Clinical Outcome Assessments (COA) Qualification Program Submissions
          Qualified Clinical Outcome Assessments (COA) Home
          Drugs
          Development & Approval Process | Drugs
          Drug Development Tool (DDT) Qualification Programs
          Clinical Outcome Assessment (COA) Qualification ProgramDrug Development Tool (DDT) Qualification Programs Clinical Outcome Assessment (COA) Qualification Program
  	
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    PrintCDER & CBER’s DDT Qualification Project Search Database

Locate a project or a qualified Clinical Outcome Assessment on CDER & CBER’s DDT Qualification Project Search database

The CDER Clinical Outcome Assessment (COA) Qualification Program

Manages the qualification process for COAs intended to address unmet public health needs.
	Works directly with requestors in guiding COA development for qualification.
	Encourages a collaborative, multidisciplinary setting where CDER can review COAs and provide advice on the development or modification of COAs outside the IND/NDA/BLA pathway.COA Qualification

COA qualification is a regulatory conclusion that the COA is a *well-defined and reliable assessment*of a specified concept of interest for use in adequate and well-controlled (A&WC) studies in a specified context of use. COA qualification represents a conclusion that within the stated context of use, results of assessment can be relied upon to measure a specific concept and have a specific interpretation and application in drug development and regulatory decision-making.

If you are interested in potentially participating in the qualification program, we highly encourage you to watch the **COA Qualification Program orientation session** to learn valuable information related to the qualification process requirements. You may also download the slide deck.

Please be advised that formal regulatory qualification is a multi-year process. Qualification is not required for a COA to be successfully used in clinical trials and drug development to support regulatory decision making.


Contact us at:COADDTQualification@fda.hhs.gov
Sub-Topic Paragraphs
          Resources for YouFrequently Asked Questions
            Find answers about Clinical Outcome Assessment Qualification ProgramResources
            Learn about COAQP stages & submissions and subscribe to program updatesClinical Outcome Assessments (COA) Qualification Program Submissions
            Submissions which final COA qualification determinations have not yet been madeQualified Clinical Outcome Assessments (COA)
            Information updated biannuallyDivision of Clinical Outcome Assessment (DCOA)
            Information about more  COA programsDrug Development Tools | DDTs
            Qualification programs to support DDT development

                                                                                  Content current as of:
      10/27/2023
                  
                   
Regulated Product(s)
		 DrugsTopic(s)
			  Research
				    				       				    					
				  
				    
				  Drug Development ToolsLaw(s) & Regulation(s)
			  21st Century Cures Act of 2016Clinical Outcome Assessment (COA) Qualification Program                
                          

                        Clinical Outcome Assessment (COA) Qualification Program: Frequently Asked Questions
          Clinical Outcome Assessments  (COA) Qualification Program Resources
          Clinical Outcome Assessments (COA) Qualification Program Submissions
          Qualified Clinical Outcome Assessments (COA)
 
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