US FDA Announces OTC Monograph Drug User Fee Rates, Giving 45 Days For First Facility Payments
The FDA says the new OTC monograph drug user-fee program (OMUFA) will provide additional resources needed to support the streamlined regulatory activities described by OTC drug reform legislation enacted in March 2020.
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FDA publishes second notice on FY2021 rates for OTC monograph drug user fee program. With fewer firms paying, those still subject to facility fees will pay more so the total collected matches amount Congress authorized agency to collect, nearly $23.3m.
Rates published in December for FY2021 monograph user fee program prompted immediate questions and opposition. HHS says fee schedule is being withdrawn because the document “was issued without approval of the Secretary.”
CDER’s Office of Nonprescription Drugs is “hitting the deck running’” hiring and training staff following passage of OTC monograph reform with user fees to support adding staff and a reshuffling earlier in 2020, says Peter Stein, Office of New Drugs director.