The number of manufacturing sites subject to facility fees under for the Food and Drug Administration’s OTC monograph drug user fee program (OMUFA) is down and the amounts each facility will pay for fiscal year 2022 are up.
Firms that submit OTC monograph order requests to the FDA also will pay more under the FY2022 OMUFA rates the Office of Nonprescription Drugs in the Center for Drug Evaluation and Research stated in a
The notice, docket FDA-2022-N-0284, states that the total facility registration fees for FY2022, which ends on 30 September, is calculated