For Industry
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Biosimilar and Interchangeable Products User Fee Meetings
FDA has been conducting discussions with public and industry stakeholders regarding the development of a 351(k) user fee program for fiscal years 2013-2017. This page contains information concerning those discussions.
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Industry Stakeholder Meetings
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Related Information
Biosimilars FDA requests input on development of user fee program for biosimilar and interchangeable biological products Proposed Biosimilar Biological Product Authorization Performance Goals and Procedures Fiscal Years 2013 through 2017 (PDF - 89KB)Transcript, Biosimilars User Fee Program Public Meeting, December 16, 2011 (PDF - 117KB)- Proposed Recommendations for a Biosimilars User Fee Program - Notice of Public Meeting
Proposed Biosimilars User Fee Act Statutory Language (PDF - 68KB)
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