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Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process

 
• By Malcolm Spicer

The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFL isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.

The proposed rule was issued on 27 June and intended to broaden the range of nonprescription drugs available. • Source: Shutterstock

Increasing over-the-counter switches in the US will add “ACNU” to regulatory jargon and flexibility to the Food and Drug Administration’s drug approval process, allowing the same ingredient at the same dose to remain available for prescription after being approved for nonprescription sales, according to a proposed rule.

The FDA’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule published on 27 June –...

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