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 In this section:

        Drug Development Tool (DDT) Qualification Programs

Animal Model Qualification Program | AMQP

                        
                Animal Model Qualification: Frequently Asked Questions (FAQs)
          The Animal Model Qualification Process Home
          Drugs
          Development & Approval Process | Drugs
          Drug Development Tool (DDT) Qualification Programs
          Animal Model Qualification Program | AMQPDrug Development Tool (DDT) Qualification Programs Animal Model Qualification Program | AMQP
  	
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*A product-independent, resource-conserving approach to advance the development of animal models for use in Animal Rule applications*
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                    Overview of the Animal Model Qualification Program
            Learn about the program and how it can help advance the development of critically needed animal models for products developed under the Animal Rule
          
          Regulations

                    Animal Rule Information
            Learn about the regulations for the approval of new drugs and biological products when human efficacy studies are not ethical or feasible
    
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                    The Animal Model Qualification Process
            Learn about the process and access submission content outlines
    
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                    Submit to the Animal Model Qualification Program
            Get contact and submission information for the Animal Model Qualification Program
    
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                    Resources for the Animal Model Qualification Program
            Find useful resources, including guidances and websites
    
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                    Frequently Asked Questions
            About the Animal Model Qualification Program

                                                                                  Content current as of:
      04/04/2023
                  
                   
Regulated Product(s)
		 DrugsTopic(s)
			  Research
				    				       				    					
				  
				    
				  Drug Development ToolsLaw(s) & Regulation(s)
			  21st Century Cures Act of 2016Animal Model Qualification Program | AMQP                
                          

                        Animal Model Qualification: Frequently Asked Questions (FAQs)
          The Animal Model Qualification Process
 
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