OTC Monograph Drug User Fee Amendments (OMUFA): FY 2026 User Fees and Registration
U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) webinar · July 20, 2026
FDA officials briefed industry on the OTC Monograph User Fee Amendments (OMUFA 2), explaining new fee due dates and liability periods, FY2026 fee amounts and target revenue, payment procedures, penalties for nonpayment, and refund rules. Presenters answered audience questions about registration timing, invoice classifications, and fee disputes.
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