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FDA Begins Modernizing Its Resources And Implementing Over-The-Counter Monograph User Fee Requirements - Food, Drugs, Healthcare, Life Sciences

By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill. ....

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FDA advisers to consider giving green light to Pfizer booster

FDA advisers to consider giving green light to Pfizer booster
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FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates | King & Spalding

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Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for OTC monograph drug product contract manufacturing organizations (“CMOs”). The annual facility fee for OTC monograph drug manufacturers – the so-called Monograph Drug Facility (“MDF”) fee – was set at $14,060,[i] and the annual facility fee for CMOs was set at $9,373.[ii] According to the notice, for FY 2021, facility fees would have come due February 12, 2021.[iii]
However, just two days later, on December 31, 2020, the Department of Health and Human Services (“HHS”) withdrew the FDA notice and directed FDA to cease enforcement of the OTC user fees[iv] at least for the time being. HHS’ action responded to criticism that fees would apply to OTC hand sanitizer manufact ....

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