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 In this section:

                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: Biosimilar User Fee Act (BsUFA) PerformanceFDA-TRACK: Agency-wide Program Performance FDA-TRACK: Biosimilar User Fee Act (BsUFA) Performance
  
  	
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Biosimilar Applications and Supplements

Procedural Notifications

Procedural Responses

Meeting
Management

• Current Performance
	• Historical Performance

• Current Performance
	• Historical Performance

• Current Performance
	• Historical Performance

• Current Performance
	• Historical Performance


Relevant Links:

• BsUFA II Commitment Letter
	• BsUFA Authorization
	• Biosimilar User Fee Amendments
	• Biosimilar Definitions
	• BsUFA Reauthorization Act
	• BsUFA Performance Reports
	• FDA-TRACK: CDER Biosimilars Dashboard


The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.


The Biosimilar User Fee Performance Dashboards (BsUFA Dashboards) provide a concise, interactive, and visual presentation of data that is presented in the legislatively mandated FY 2022 BsUFA Performance Report to Congress for the Biosimilar User Fee Act (the Report). The BsUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The BsUFA Dashboards reflect performance on submissions received and actions taken as of September 30, 2022. The BsUFA Dashboards present final performance in meeting BsUFA goals for FY 2021 and preliminary performance for FY 2022. Final BsUFA performance data for FY 2022 will be presented in the FY 2023 BsUFA Report and referenced in updated versions of the BsUFA Dashboards.

Biosimilar Applications and Supplements

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

Original Biosimilar Product Applications
	Resubmitted Biosimilar Product Original Applications
	Original Supplements with Clinical Data
	Manufacturing Supplements Requiring Prior Approval
	Manufacturing Supplements Not Requiring Prior Approval

Procedural Notifications

The Procedural Notifications Dashboard displays current performance relating to the notification/review of:

Issues Identified During Filing Review for Original Applications and Supplements with Clinical Data
	Planned Review Timeline for Original Applications with Clinical Data
	Proprietary Names Submitted During Biosimilar Biological Product Development (BPD) Phase and During Application Review

Procedural Responses

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

Major Dispute Resolutions
	Responses to Clinical Holds
	Special Protocol Assessments

Meeting Management

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

Meeting Requests
	Scheduling Meetings
	Written Responses
	Preliminary Responses
	Meeting Minutes

                                                                                  Content current as of:
      01/31/2023FDA-TRACK: Agency-wide Program Performance

          
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