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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK User Fee Newsletter - January 20, 2022

FDA-TRACK User Fee Newsletter - January 20, 2022

FDA-TRACK Releases Latest User Fee Performance Data

FDA-TRACK is releasing the latest annual User Fee Program data for animal and human drug and biosimilar products. Final review performance results for FY 2020 and preliminary performance results for FY 2021 are now available. The FDA utilizes the User Fee Programs to assess and collect fees to fulfill its mission of protecting the public health and accelerating innovation in the industry. The User Fee performance dashboards provide a concise, interactive, and visual presentation of the data in the legislatively-mandated Performance Reports to Congress.

Human Drug and Biosimilar Products

  • Prescription Drug User Fee Act (PDUFA):
     
    • Applications and Supplements: FDA met or exceeded the performance level for 10 out of 12 review goals for FY 2020 final performance. Across all review goals, FDA met the review-time goal for 3,300 out of 3,433 submissions. FDA is currently meeting or exceeding the performance level for 9 out of 12 review goals for FY 2021 preliminary performance.
    • Procedural Notifications and Responses: FDA met or exceeded the performance level for 5 out of 6 procedural goals for FY 2020 final performance. Across all procedural notification goals, FDA met the review-time goal for 955 of 1,002 submissions. FDA is currently meeting or exceeding the performance level for 5 out of 6 procedural goals for FY2021 preliminary performance.
    • Meeting Management: FDA met or exceeded the performance level for 3 out of 14 meeting management goals for FY 2020 final performance. Across all meeting management goals, FDA met the review-time goal for 9,351 of 10,981 submissions. FDA is currently meeting or exceeding the performance level for 4 out of 14 meeting management goals for FY 2021 preliminary performance.  
       
  • Biosilmilar User Fee Act (BsUFA):
     
    • Applications and Supplements: FDA met or exceeded the performance level for 5 out of 6 review goals for FY 2020 final performance. Across all review goals, FDA met the review-time goal for 79 of 86 submissions. FDA is currently meeting or exceeding the performance level for 6 out of 6 review goals for FY 2021 preliminary performance. 
    • Procedural Notifications: FDA met or exceeded the performance level for 4 out of 4 procedural notification goals for FY 2020 final performance. Across all procedural notification goals, FDA met the review-time goal for 18 of 18 submissions. FDA is currently meeting or exceeding the performance level for 4 out of 4 procedural notification goals for FY2021 preliminary performance.
    • Procedural Responses: FDA met or exceeded the performance level for 0 out of 3 procedural response goals for FY 2020 final performance. Note, no submissions were received for 2 of 3 goals. Across all meeting management goals, FDA met the review-time goal for 241 of 280 submissions. FDA is currently meeting or exceeding the performance level for 4 out of 15 meeting management goals for FY2021 preliminary performance. Note, no submissions were received for 1 of 3 goals.
    • Meeting Management: FDA met or exceeded the performance level for 8 out of 15 meeting management goals for FY 2020 final performance. Across all meeting management goals, FDA met the review-time goal for 241 of 280 submissions. FDA is currently meeting or exceeding the performance level for 4 out of 15 meeting management goals for FY 2021 preliminary performance. 

Animal Drug Products

  • Animal Drug User Fee Act (ADUFA):
    • FDA exceeded the performance level for all 9 review goals for FY 2020 final performance. Across all review goals, FDA met the review-time goal for 954 of 973 submissions. FDA is currently exceeding the performance level for all 9 review goals for FY 2021 preliminary performance. 
       
  • Animal Generic Drug User Fee Act (AGDUFA):
    • FDA exceeded the performance level for all 5 review goals for FY 2020 final performance. Across all review goals, FDA met the review-time goal for 379 of 396 submissions. FDA is currently exceeding the performance level for all 5 review goals for FY 2021 preliminary performance. 

For more information about FDA-TRACK and what other Centers across FDA are tracking, please visit our FDA Track Home Page and our What's New Page.

 

 

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