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US FDA Checking Boxes On OTC Monograph Overhaul And In-Box For ACNU Switch Comments

‘Different’ OTC Space Coming From Monograph Program Reform, Proposed OTC Switch Changes

Executive Summary

“Who would have said that, looking forward two or three years ago, we would be where we are now?” says FDA OTC office director Theresa Michele. Monograph reform and introducing “additional conditions for nonprescription use” options for NDA OTCs each is a “real gamechanger.”

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