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:

                Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review

                        Fast Track
          Breakthrough Therapy
          Accelerated Approval
          Priority Review Home
          For Patients
          Learn About Drug and Device Approvals
          Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
          Priority ReviewFast Track, Breakthrough Therapy, Accelerated Approval, Priority Review Priority Review
  
  	
    Share
    Post
    Linkedin

    Email
    PrintPrior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – *Standard Review*and *Priority Review*. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review).A *Priority Review*designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.Significant improvement may be demonstrated by the following examples:evidence of increased effectiveness in treatment, prevention, or diagnosis of condition;elimination or substantial reduction of a treatment-limiting drug reaction;documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; orevidence of safety and effectiveness in a new subpopulation.FDA decides on the review designation for every application. However, an applicant may expressly request priority review as described in the Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics. It does not affect the length of the clinical trial period. FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement. Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary.

                                                                                  Content current as of:
      01/04/2018Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review

          
                        Fast Track
          Breakthrough Therapy
          Accelerated Approval
          Priority Review
 
 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