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 In this section:

                Development & Approval Process | Drugs

Development & Approval Process | Drugs

                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources Home
          Drugs
          Development & Approval Process | Drugs
          Drug Development Tools | DDTsDevelopment & Approval Process | Drugs Drug Development Tools | DDTs
  
  	
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DDTs are methods, materials, or measures that can potentially facilitate drug development. FDA established qualification programs to support DDT development.

General DDT and Contact Information

Drug Development Tool Qualification Programs
	Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
	Drug Development Tool Qualification Programs ContactsDDT Qualification and Submission Process

Drug Development Tool Qualification Process
	Drug Development Tool Qualification Process: Transparency Provisions
	Drug Development Tool Submissions ProcessDDT Qualification Programs

Animal Model Qualification Program
	Biomarker Qualification Program
	Clinical Outcome Assessments (COA) Qualification ProgramDDT Resources

Additional Drug Development Tool Resources

                                                                                  Content current as of:
      06/13/2019
              
              
Regulated Product(s)
		 DrugsTopic(s)
			  Research
				    				       				    					
				  
				    
				  Drug Development ToolsLaw(s) & Regulation(s)
			  21st Century Cures Act of 2016Development & Approval Process | Drugs

          
                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources
 
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