Firms submitting but then withdrawing requests for changes to the US OTC monograph program will have multiple chances to appeal for refunds of user fees they pay the Food and Drug Administration to file the requests, according to a draft guidance from the agency.
US FDA Allows Multiple OMUFA Refund Appeals
Monograph User Fee Draft Guidance Also Details One Registration Fee For Multi-Site Facility
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 But refunds aren’t so simple if an OMOR is withdrawn later in process.
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