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  4. Biosimilar User Fee Amendments
  5. Completed BsUFA III Deliverables
  1. Biosimilar User Fee Amendments

Completed BsUFA III Deliverables

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products. BsUFA must be reauthorized every five years, and in September 2022, the President signed into law the third reauthorization of BsUFA, which establishes the program through fiscal year 2027.

To provide a snapshot of how FDA is meeting some of its BsUFA commitments, the following tables present a listing of required and completed deliverables. Many of these deliverables can be found elsewhere on FDA's website but have been consolidated here for ease of access.

Please note:

  • The tables focus on external activities or deliverables such as guidances, public meetings, public workshops, and updates or documents posted to the FDA website.
  • The tables include the original deliverables FDA produced to meet its commitments, but they do not necessarily include more recent versions that may have posted after the deliverables were met.
  • For more detailed and complete information regarding BsUFA performance progress, please see the BsUFA Annual Performance Report page.

Recurring Commitments

This table includes commitments that require regular updates (e.g., annually, quarterly).

Commitment Topic Recurrence
Publish Quarterly Hiring Updates Set Clear Goals for Human Drug Review Program Hiring Quarterly
Develop and Update Data and Tech Modernization Strategy Information Technology Goals   Annually
Electronic Submission Gateway (ESG) Website Update Monitor and Modernize ESG Annually
Publish Financial Plan and Annual Updates Financial Transparency Annually 

Other Commitments

This table includes other commitments, that do not have a regular update (e.g., guidances, public meetings).

Commitment Topic Date Published
Publish Capacity Planning Implementation Plan Resource Capacity Planning Implementation 3/29/2023
Publish 5 Year Financial Plan Financial Transparency 4/18/2023
Conduct Public Meeting Financial Plan FY23 Financial Transparency 6/8/2023
Publish Draft Supplements Guidance Guidance 8/11/2023
Publish Revised Draft Guidance on Changes to Meeting Management Guidance, Clarity, and Transparency 8/11/2023
Publish Draft Guidance on Labeling for Interchangeable Biosimilars Foundational Guidance Development 9/18/2023
Publish Draft Guidance on Alternative Tools to Assess Manufacturing Facilities Inspections and Alternative Tools to Evaluate Facilities 9/22/2023
Update Relevant Documents Regarding Best Practices in Communication with Sponsors & Update Relevant MAPPS and SOPPs on Communication with Sponsors  Promoting Best Practices in Communication Between FDA and Sponsors  12/26/2023
Publish Capacity Planning Implementation Plan Updates FY24 Resource Capacity Planning Implementation 3/22/2024
Publish Draft Guidance on Promotional Labeling and Advertising for Interchangeable Biosimilars Advancing Development of Interchangeable Biosimilar Biological Products     4/25/2024 
Publish Combo Products Guidance Related to URRAs Advancing The Development of Biosimilar Biological Device Combination Products Regulated by CDER and CBER 7/8/2024
Publish Draft Guidance on Post Approval Manufacturing Changes Advancing Development of Interchangeable Biosimilar Biological Products 7/23/2024

 

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