Total facility registration fees in the US OTC monograph user fee program are up for fiscal year 2023 as the fees each manufacturer will pay increase 8% from FY2022.
US OTC Monograph Drug Facility Fees Up 8%, Higher Price Tags Stuck On OMORs, Too
FY2023 OTC monograph user fee target facility fee revenue is $25.4m from manufacturers’ fees of $26,153 and contract manufacturers’ fees of $17,435, all due by 1 June. OMOR fees are $517,381 for Tier 1 requests and $103,476 for Tier 2.

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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.