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OTC Monograph Woes No Surprise To FDA Commissioner Nominee Gottlieb

Executive Summary

Gottlieb was asked only one question about OTC drug regulation during his confirmation hearing before the Senate HELP Committee, but it covered a large part of FDA's current concerns about the OTC market.

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Hatch Closing Act: OTC Monograph Reform Legislation?

The Utah Republican has been instrumental during his more than 40 years in office in passing legislation central to the growth of the OTC drug and dietary supplement industries. But the expansion of the OTC market is stifled by FDA's monograph system for making more ingredients available, a process agency officials say no longer works.

Hatch Closing Act: OTC Monograph Reform Legislation?

The Utah Republican has been instrumental during his more than 40 years in office in passing legislation central to the growth of the OTC drug and dietary supplement industries. But the expansion of the OTC market is stifled by FDA's monograph system for making more ingredients available, a process agency officials say no longer works.

OTC Monograph User Fee Goals Document Beats Authorization To Finish Line

While still awaiting the addition of OTC user fees to pending user fee authorization, and congressional approval of the overall package, FDA has developed guidelines closely tracking Sens. Isakson and Casey's OTC proposal. FDA plans a webinar to update industry on how OTC user fees would work.

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