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FDA Announcement on User Fees for the Over-the-Counter (OTC) Drug Program for FY 2021

On March 26, 2021, the FDA announced it will collect OTC user fees for Fiscal Year 2021 from owners of OTC Monograph Facilities that were in operation for the period from January 2020 through December 2020. As we previously...more

HHS Withdraws FDA’s “Arbitrary, Surprise” OTC User Fee and ‎Proposals for FY 2021

As is typical with the FDA, the Agency chose the end of the year to publish the fees it intended to ‎collect from over-the-counter (OTC) monograph drug manufacturers under the OTC Monograph User ‎Fee Act (OMUFA). In its...more

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