BsUFA Federal Register and Guidance Documents
Federal Register Documents
- Biosimilar User Fee Rates for Fiscal Year 2018
- Biosimilar User Fee Rates for Fiscal Year 2017
- Biosimilar User Fee Rates for Fiscal Year 2016
- Interim Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications
- Biosimilar User Fee Rates for Fiscal Year 2015
- Biosimilar User Fee Rates for Fiscal Year 2014
- Biosimilar User Fee Rates for Fiscal Year 2013
- Proposed Recommendations for a Biosimilars User Fee Program - Notice of Public Meeting
- Options for a Biosimilar User Fee Program - Request for Comments
- Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting