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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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 HHS says fee schedule is being withdrawn because the document “was issued without approval of the Secretary.”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.
It’s unlikely any industry stakeholder or FDA official expected a bill providing emergency economic relief to consumers, industries and health care services and facilities in response to a pandemic, including extensive support opportunities for small businesses, would be the vehicle that delivers on both of the industry’s congressional wishes. The supplement industry also looks for help in CARES Act.