FDA Announces OTC Monograph Drug Facility Fee Rates for Fiscal Year 2025
March 21, 2025
March 21, 2025
WASHINGTON, March 21 (TNSFR) -- The Food and Drug Administration (FDA) has announced the fiscal year (FY) 2025 facility fee rates for the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA). These fees, which apply to manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs), will take effect on October 1, 2024, and remain in place through September 30, 2025.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is author . . .
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is author . . .