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                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: Animal Drug User Fee Act (ADUFA) PerformanceFDA-TRACK: Agency-wide Program Performance FDA-TRACK: Animal Drug User Fee Act (ADUFA) Performance
  
  	
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Animal Drug Applications and Supplements

• Current Performance

• Historical Performance


Relevant Links:

• ADUFA IV Performance Goals and Procedures
	• ADUFA Performance Reports
	• ADUFA Report Information
	• ADUFA Meetings
	• FDA-TRACK: CVM Dashboards


On August 14, 2018, the third reauthorization of the Animal Drug User Fee Act (ADUFA), referred to as ADUFA IV, was signed into law. ADUFA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing ADUFA for an additional five years (FY 2019 through FY 2023). ADUFA provides FDA with revenue to enhance the performance and predictability in review times for the animal drug industry and provides FDA with resources to improve its review of applications for new animal drugs, with the result that safe and effective new products will be more readily available.


The Animal Drug User Fee Performance Dashboards (ADUFA Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated ADUFA Performance Report to Congress for the Animal Drug User Fee Act (the Report). The ADUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The ADUFA Dashboards reflect performance on submissions received and actions taken as of September 30, 2023. The ADUFA Dashboards present final performance in meeting ADUFA goals for FY 2022 and preliminary performance for FY 2023. Final ADUFA performance data for FY 2023 will be presented in the FY 2024 ADUFA Report and referenced in updated versions of the ADUFA Dashboards.

Animal Drug Applications and Supplements

The Animal Drug Applications and Supplements Dashboard displays current performance relating to the review of:

Original New Animal Drug Applications (NADAs) and Reactivations
	Administrative NADAs
	Non-Manufacturing Supplemental NADAs and Reactivations
	Manufacturing Supplemental NADAs and Reactivations
	Labeling Supplements
	Investigational New Animal Drug (INAD) Study Submissions
	INAD Protocol Submissions
	Presubmission Conference
	Tissue Residue Method Demonstrations

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

          
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