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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

 
• By Malcolm Spicer

“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.”

• Source: Shutterstock

The Food and Drug Administration’s regulation of the US OTC drug space is being overhauled through changes to its monograph program made within deadlines set by Congress and a proposal to extend labeling for nonprescription drugs into the digital realm.

However, what access to nonprescription drugs will look like after monograph reform is completed and if “additional conditions for nonprescription use” (ACNU) options for OTC switch new drug applications become...

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