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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Prescription Drug User Fee Act (PDUFA) Performance

 

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FDA-TRACK: CDER
FDA-TRACK: Biologics
PDUFA Performance Dashboard User Guide
FDA-TRACK Home Page

Prescription Drug Applications and Supplements

Procedural Notifications and Responses

Meeting
Management

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2022 (PDUFA VII), authorizes FDA to assess and collect fees for prescription drug products from October 2023 through September 2027. 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 2023 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, 2023. The PDUFA Dashboards present final performance in meeting PDUFA goals for FY 2022 and preliminary performance for FY 2023. Final PDUFA performance data for FY 2023 will be presented in the FY 2024 PDUFA Report and referenced in updated versions of the PDUFA Dashboards.

FDA-Track icon: PDUFA Prescription Drug Applications and Supplements

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 Resubmitted NDAs and BLAs
  • Class 2 Resubmitted NDAs and BLAs
  • Class 1 and Class 2 Resubmitted NDAs and BLAs
  • Priority and Standard NDA and BLA Efficacy Supplements
  • Class 1 Resubmitted NDA and BLA Efficacy Supplements
  • Class 2 Resubmitted 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

Procedural Notifications and Responses

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

  • Response to Clinical Holds
  • Major Dispute Resolutions
  • Special Protocol Assessments
  • Proprietary Names Submitted During Investigational New Drug (IND) Phase and Submitted During NDA/BLA Phase
  • Human Factors Protocol Submissions to NDAs, BLAs, or INDs
  • Human Factors Protocol Submissions to INDs
  • Priority NME NDA and Original BLA Postmarketing Requirements (PMRs)
  • Standard NME NDA and Original BLA PMRs
FDA-TRACK: PDUFA Procedural Notifications and Responses
FDA-TRACK icon: PDUFA Meeting Management

Meeting Management

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

  • Type A, B, B(EOP), C, D, and INTERACT Meeting Requests
  • Type A, B, B(EOP), C, D, and INTERACT Meetings Scheduled
  • Type A, B, B(EOP), C, D, and INTERACT Written Responses
  • Preliminary Responses for Type B(EOP), D, and INTERACT Meetings
  • Meeting Minutes

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