FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates
By EsqSocial Corporation 06/01/21
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, and the annual facility fee for CMOs was set at $9,373. According to...
By: King & Spalding