US OTC Monograph Drug Facility Fees Up 8%, Higher Price Tags Stuck On OMORs, Too
Executive Summary
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.
You may also be interested in...
FDA Delivers OTC Monograph Facility Fees For Fiscal 2024 With Highlights On Some RSVPs
FDA “is highlighting” in its FY2024 facility fees announcement, and using italics for “emphasis added” for some statements, that businesses previously but no longer making hand sanitizers, though still selling the products, should contact the agency to assure they’re not assessed fees.
US FDA Electronic Drug Registrations Key For OTC Monograph Fees Plus Keeping Tabs On Products
FDA drug user fee program chief tells OTC industry stakeholders accurate information in electronic Drug Registration and Listing System is key to setting annual facility registration user fee rates. CDER publishes warning letters to US retailer and a South Korean manufacturer noting noncompliance with eDRLS requirements.
US FDA Asks For Comments On Reauthorizing OMUFA, A Program Still New To OTC Industry
Agency conducting all-day online meeting on 28 September to discuss proposed first reauthorization of OMUFA program established with its first five-year authorization in 2020 in legislation to overhaul the OTC monograph program.