US OTC Monograph Drug Facility Fees Up 8%, Higher Price Tags Stuck On OMORs, Too
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.
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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.
US OTC Monograph Overhaul Like Makeover To Resemble Other FDA Drug Application Programs
In draft guidance on format and content for OMORs, CDER framed recommendations by same model it’s used for guidances on other drug applications, common technical document for registration developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
US FDA Allows Multiple OMUFA Refund Appeals
Draft acknowledges firms likely will expect refunds when they withdraw OMORs. When sponsor withdraws OMOR before FDA accepts or refuses to file, agency will refund 75% of the without a written request. But refunds aren’t so simple if an OMOR is withdrawn later in process.