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        Learn About Drug and Device Approvals

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review

                        
                Fast Track
          Breakthrough Therapy
          Accelerated Approval
          Priority Review Home
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          Learn About Drug and Device Approvals
          Fast Track, Breakthrough Therapy, Accelerated Approval, Priority ReviewLearn About Drug and Device Approvals Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
  	
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    PrintSpeeding the availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments. The Food and Drug Administration has developed four distinct and successful approaches to making such drugs available as rapidly as possible:

Priority Review
	Breakthrough Therapy
	Accelerated Approval
	Fast TrackBecause each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them.

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Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.**Fast Track**



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A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.**Breakthrough Therapy**



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These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint.**Accelerated Approval**



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A Priority Review designation means FDA’s goal is to take action on an application within 6 months. **Priority Review**



Resources For You

MedWatch

                                                                                  Content current as of:
      06/12/2023Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review                
                          

                        Fast Track
          Breakthrough Therapy
          Accelerated Approval
          Priority Review
 
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