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 In this section:

                FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Agency-wide Program Performance

                        FDA-TRACK: What's New
          FDA-TRACK: User Fee Performance
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          FDA-TRACK: Agency-wide Program Performance
          FDA-TRACK: User Fee PerformanceFDA-TRACK: Agency-wide Program Performance FDA-TRACK: User Fee Performance
  
  	
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PDUFA

The Prescription Drug User Fee Act (PDUFA) authorizes FDA (specifically the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER)) to assess and collect fees for prescription drug products. FDA dedicates these fees toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities.

BsUFA

The Biosimilar User Fee Act (BsUFA) authorizes FDA (specifically the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER)) to assess and collect fees for biosimilar biological products. FDA dedicates these fees toward expediting the review process for biosimilar biological products. BsUFA facilitates the development of safe and effective biosimilar products for the American public.

ADUFA

The Animal Drug User Fee Act (ADUFA) authorizes FDA (specifically the Center for Veterinary Medicine) to assess and collect fees for new animal drug products. ADUFA provides FDA with resources to enhance the performance and predictability of the new animal drug review process, resulting in the approval of safe and effective animal drug products.

AGDUFA

The Animal Generic Drug User Fee Act (AGDUFA) authorizes FDA (specifically the Center for Veterinary Medicine) to assess and collect fees for generic new animal drug products. AGDUFA provides FDA with resources to enhance the performance and predictability of the generic new animal drug review process, resulting in the approval of safe and effective animal drug products.

                                                                                  Content current as of:
      12/14/2023FDA-TRACK: Agency-wide Program Performance

          
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