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  1. FDA-TRACK: Agency-wide Program Performance

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

 

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FDA-TRACK: CDER
FDA-TRACK: Biologics
PDUFA Performance Dashboards 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 2025 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 charts in the PDUFA Dashboards present PDUFA goal performance for three fiscal years (FY), FY 2024 - FY 2026. While FY 2024 data is considered final, FY 2025 and FY 2026 data are preliminary and updated on a quarterly basis. Final PDUFA performance data for FY 2025 will be presented in the FY 2026 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 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

Procedural Notifications and Responses

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

  • Major Dispute Resolutions
  • Responses to Clinical Holds
  • Special Protocol Assessments
  • Proprietary Names Submitted During Investigational New Drug (IND) Phase and Submitted During NDA/BLA Phase
  • Human Factors Validation Protocol Submissions to INDs
  • Use-Related Risk Analysis Submissions
  • Risk Evaluation Mitigation Strategy (REMS) Assessment Methods and Protocols
  • Priority and Standard NME NDA and Original BLA Postmarketing Requirements (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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