FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees
By EsqSocial Corporation 02/04/21
On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.” The CARES Act, passed by Congress on March 27, 2020, established OMUFA, FDA’s newest user fee program, which granted FDA the ability to assess and collect two types of fees: OTC monograph drug facility (MDF)...
By: Womble Bond Dickinson