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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: PDUFA Performance

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2017 (PDUFA VI), authorizes FDA to assess and collect fees for prescription drug products from October 2017 through September 2022. 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. The Prescription Drug User Fee Performance Dashboards (PDUFA Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated FY 2019 PDUFA Performance Report to Congress for the Prescription Drug User Fee Act (the Report). The PDUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The PDUFA Dashboards reflect performance on submissions received and actions taken as of September 30, 2019. The PDUFA Dashboards present final performance in meeting PDUFA goals for FY 2018 and preliminary performance for FY 2019. Final PDUFA performance data for FY 2019 will be presented in the FY 2020 PDUFA Report and referenced in updated versions of the PDUFA Dashboards.

PDUFA Performance Dashboard User Guide

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Prescription Drug Applications and Supplements

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

  • Original Priority and Standard New Molecular Entities (NMEs) and Biologics License Applications (BLAs)
  • Original Priority and Standard non-NME New Drug Applications (NDAs)
  • Class 1 and Class 2 Resubmitted NDAs and BLAs
  • Priority and Standard NDA and BLA Efficacy Supplements
  • Class 1 and Class 2 Resubmitted NDA and BLA Efficacy Supplements
  • NDA and BLA Manufacturing Supplements Requiring Prior Approval
  • NDA and BLA Manufacturing Supplements Not Requiring Prior Approval

For historical performance goals, please see the Historical Performance: Prescription Drug Applications and Supplements Dashboard.


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Procedural Notifications and Responses

The Procedural Notifications and Responses Dashboard displays current performance relating to the review of/responses to:

  • Proprietary Names Submitted During Investigational New Drug (IND) Phase and Submitted with NDA/BLA
  • Major Dispute Resolutions
  • Responses to Clinical Holds
  • Special Protocol Assessments
  • Human Factors Protocol Submissions

For historical performance goals, please see the Historical Performance: Procedural Notifications and Responses Dashboard.


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Meeting Management

The Meeting Management Dashboard displays current performance relating to the responses to/issuance of:

  • Meeting Requests
  • Scheduling Meetings
  • Written Responses
  • Preliminary Responses
  • Meeting Minutes

For historical performance goals, please see the Historical Performance: Meeting Management Dashboard.


Relevant Links

 

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