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

Executive Summary

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.

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A New OTC Pathway At Last: The Acronym Isn’t The Only Thing That’s Changed

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