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Monograph User Fee Draft Guidance Also Details One Registration Fee For Multi-Site Facility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 But refunds aren’t so simple if an OMOR is withdrawn later in process.
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