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Approvals FDA Regulation

US FDA’s Slow Start To Approvals In 2019: Don’t Panic

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Executive Summary

US FDA approved just six new molecular entities in the first quarter of 2019, which seems like quite a letdown after a record-setting year in 2018. But don’t despair: the pattern of NME approvals was back-loaded a year ago – and should be again this year.

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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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