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
On January 12, 2021, the Department of Health and Human Services issued yet another Federal Register notice announcing that Persons that Entered the Over the Counter drug market to supply hand sanitizers during the COVID-19...more
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