The US Food and Drug Administration’s work to modernize and streamline its OTC monograph system has reached the point in its fourth year that the agency, for the first time, published user fee rates for change requests before the start of fiscal year and separate from facility fees.
OTC Monograph FY2024 Proposal Fees Published As FDA Anticipates Change Requests Starting
“The agency anticipates a greater likelihood of OMOR submissions compared to prior fiscal years,” CDER says. In fourth year of initial five-year authorization of OMUFA, FDA getting ready to receive OMOR submissions from drug firms and other industry stakeholders.
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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.