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Home » Drug Industry Seeks Clarity on FDA Biosimilar User Fees
Drug Industry Seeks Clarity on FDA Biosimilar User Fees
June 18, 2013
Drugmakers used comments to an FDA draft guidance on formal agency meetings for biosimilars to push for clarity on biosimilar user fees, with one company, Mylan, arguing the fees should be lower than those paid for drugs beholden to PDUFA requirements.