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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: BsUFA Performance

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 2018 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, 2018. The BsUFA Dashboards present final performance in meeting BsUFA goals for FY 2017 and preliminary performance for FY 2018. Final BsUFA performance data for FY 2018 will be presented in the FY 2019 BsUFA Report and referenced in updated versions of the BsUFA Dashboards.

BsUFA Performance Dashboard User Guide

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Biosimilar Applications and Supplements

The Biosimilar Applications and Supplements Dashboard displays current performance relating to Original Applications, Resubmitted Original Applications, Original Supplements with Clinical Data, Manufacturing Supplements Requiring Prior Approval, and Manufacturing Supplements Not Requiring Prior Approval. For historical performance goals, please see the Historical Performance: Biosimilar Applications and Supplements Dashboard.

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Procedural Notifications

The Procedural Notifications Dashboard displays current performance relating to Notification of Issues Identified During Filing Review for Original Applications and Supplements with Clinical Data, Notification of Planned Review Timeline for Original Applications with Clinical Data, Review of Proprietary Names During Biosimilar Biological Product Development (BPD) Phase and During Application Review. For historical performance goals, please see the Historical Performance: Procedural Notifications Dashboard.

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Procedural Responses

The Procedural Responses Dashboard displays current performance relating to Major Dispute Resolutions, Responses to Clinical Holds, and Special Protocol Assessments. For historical performance goals, please see the Historical Performance: Procedural Responses Dashboard.

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Meeting Management

The Meeting Management Dashboard displays current performance relating to Responses to Meeting Requests, Scheduling Meetings, and Issuance of Meeting Minutes. For historical performance goals, please see the Historical Performance: Meeting Management Dashboard.

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