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Biosimilars FDA Regulation

FDA's Biosimilars Meeting Management Should Improve After Reorg In New Drug Office

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Executive Summary

US FDA met more biosimilar user fee program meeting performance goals in FY 2018 compared to prior year but still fell short in scheduling for three of five types of meetings. Office of New Drugs reorganization, once completed, should address some logistical scheduling issues.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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