Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Drug Development Tool (DDT) Qualification Programs

Drug Development Tool (DDT) Qualification Programs

                        


                        Animal Model Qualification Program | AMQP
          Biomarker Qualification Program
          Clinical Outcome Assessment (COA) Qualification Program
          Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program Home
          Drugs
          Development & Approval Process | Drugs
          Drug Development Tool (DDT) Qualification Programs
          Drug Development Tool Qualification Process: Transparency ProvisionsDrug Development Tool (DDT) Qualification Programs Drug Development Tool Qualification Process: Transparency Provisions
  
  	
    Share
    Post
    Linkedin

    Email
    PrintUnder the 21st Century Cures Act,1 enacted on December 13, 2016, a new section 507, Qualification of Drug2 Development Tools (DDT)3, was added to the Federal Food, Drug, and Cosmetic Act. Section 507 includes transparency provisions that apply to requestors’ submissions and FDA’s formal written determinations in response to such submissions4.

Consistent with the transparency provisions of section 507, FDA intends to publicly post the information contained in the table below. Please note that the transparency provisions of section 507 apply to Letters of Intents (LOIs), Qualification Plans (QPs), and Full Qualification Packages (FQPs) sent to FDA after December 13, 2016 (when the 21st Century Cures Act was enacted). In addition to these, FDA intends to publicly post any updates to an LOI, QP, or FQP and/or any other submission(s) that significantly impacts the DDT’s development.

The table below describes what will be publicly posted for an LOI, QP, FQP, and qualification decision, consistent with the transparency provisions of section 507. To view program specific submissions, please visit:

Animal Model Qualification Submissions
	Biomarker5Qualification Submissions
	Clinical Outcome Assessments (COA) Qualification Submissions
	CDER & CBER’s DDT Qualification Project Search databaseDDT Submission
			Documents and/or Information FDA will post on its website, consistent with new section 507(c)Letter of Intent
			(LOI)
			Date of receipt and status (under consideration, accepted, or declined)
				Requestor Name
				DDT Type (i.e. Animal Model, Biomarker, Clinical Outcome Assessment)
				DDT Name/Description
				Proposed Context of Use
				DDT Requestor's Submitted LOI Summary
				Drug development need the DDT is intended to address
				Notation if FDA consulted external experts
				FDA Formal Written Decision Letter (accepting or declining to accept the LOI)Qualification Plan (QP)
			Date of receipt and status (under consideration, accepted, or declined)
				Requestor Name
				DDT Type (i.e. Animal Model, Biomarker, Clinical Outcome Assessment)
				DDT Name/Description
				Proposed Context of Use
				DDT Requestor's Submitted QP Summary
				Notation if FDA consulted external experts
				FDA Formal Written Decision Letter (accepting or declining to accept the QP)Full Qualification Package (FQP)
			Date of receipt and status (under consideration, accepted, or declined)
				Requestor Name
				DDT Type (i.e. Animal Model, Biomarker, Clinical Outcome Assessment)
				DDT Name
				Final Context of Use
				DDT Requestor’s Submitted FQP Summary
				Notation if FDA consulted external expertsOther DocumentsQualification Determination
			Requestor Name
				DDT Type (i.e. Biomarker, Clinical Outcome Assessment)
				DDT Name
				FDA Formal Written Qualification  Determination Letter
				FDA Executive Summary including final Context of Use and DDT use considerations
				Redacted discipline-specific reviews
				FDA rescission or modification letter (if applicable)Back to Top



1 Further information regarding the 21st Century Cures Act can be found at https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf. The content section pertinent to this letter is Subtitle B – Advancing New Drug Therapies, Sec. 3011 Qualification of drug development tools, which is largely codified at section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or 21 U.S.C. 357.



2 The term drug refers to both human drugs and biological products unless otherwise specified.

3 Section 507 of the FD&C Act defines “drug development tool” to include biomarkers and clinical outcome assessments, and “any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.”

4 FD&C Act Sec. 507(c) (21 U.S.C. § 357(c)).

5 A biomarker can be a single concept or a panel of multiple concepts.



Back to Top

                                                                                  Content current as of:
      07/07/2021
              
              
Regulated Product(s)
		 DrugsTopic(s)
			  Research
				    				       				    					
				  
				    
				  Drug Development ToolsLaw(s) & Regulation(s)
			  21st Century Cures Act of 2016Drug Development Tool (DDT) Qualification Programs

          
                        


                        Animal Model Qualification Program | AMQP
          Biomarker Qualification Program
          Clinical Outcome Assessment (COA) Qualification Program
          Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop