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NME Slowdown Shows Market Pressure On Me-Toos, Not FDA Caution – Lutter

Executive Summary

DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter

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