US OTC Monograph Overhaul Meets DFO Deadline As Stakeholders Make User Fee Introductions
Last of 32 OTC monographs finalized as required in 2020 reform legislation as some stakeholders ask if the agency is collecting user fees yet.
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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.
“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.
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.