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US OTC Monograph Overhaul Meets DFO Deadline As Stakeholders Make User Fee Introductions

 
• By Malcolm Spicer

Last of 32 OTC monographs finalized as required in 2020 reform legislation as some stakeholders ask if the agency is collecting user fees yet.

• Source: Shutterstock

The Food and Drug Administration recently finalized the last of 32 OTC monographs as required in 2020 legislation overhauling its program which makes the large majority of nonprescription drugs available in the US.

Some industry stakeholders, though, might not know the agency has started the overhaul.

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