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Marketplace Results After FDA OTC Monograph Overhaul Rely On OMUFA Reauthorization

 
• By Malcolm Spicer

“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.

(Source: Shutterstock)

The OTC monograph user fee program Congress authorized in 2020 has paid for laying the groundwork for the Food and Drug Administration’s overhaul of the regulatory pathway for the large majority of drugs available nonprescription in the US.

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