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

Guidance Documents

• Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants

Related Information

• FDA requests input on development of user fee program for biosimilar and interchangeable biological products

Contact Information

• BsUFA Contacts

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