US OTC Monograph FY2022 Facility Fees Deadline In June At Amount TBD
Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.
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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.
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.
Three warnings during inspections, a warning letter and meeting with FDA officials didn’t stop Grandma’s Herbs from using drug claims. FTC reimburses consumers who bought three supplements deceptively marketed as treatments for pain and other health conditions related to aging.