• Regulatory NewsRegulatory News

    FDA FY2022 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2022 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program. Each year, FDA adjusts its user fees based on factors such as inflation and the number of applications or establishments expected to pay the various fees. For FY2022, FDA’s fee for new drug applications (ND...
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    FDA increases OTC monograph facility fees in reissued notice

    Following a dispute with the Department of Health and Human Services (HSS) that resulted in its initial notice being withdrawn, the US Food and Drug Administration (FDA) on Thursday reissued its notice announcing fee rates for its newly created over-the-counter (OTC) monograph drug user fee program (OMFUA) for FY2021.   FDA initially issued the notice on 29 December, but it was quickly withdrawn by HHS over public outcry against FDA’s plans to collect user fees fro...
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    What happened with FDA’s OTC monograph user fee notice?

    Just before the New Year, the US Food and Drug Administration (FDA) published a notice in the Federal Register announcing the fee rates it will collect for its Over-the-Counter (OTC) Monograph Drug user fee program (OMUFA) in FY2021, as it did earlier in the year for its other user fee programs.   The seemingly innocuous act proved controversial for its potential impact on liquor distillers who stepped in to manufacture hand sanitizers amid the COVID-19 pandemic an...
  • Regulatory NewsRegulatory News

    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
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    FDA Details Draft Goals for OTC Monograph User Fee Program

    After a series of discussions with industry and a public meeting in June 2016, the US Food and Drug Administration (FDA) last week released its draft goals letter for the proposed over-the-counter (OTC) monograph user fee program. The agency also announced on Tuesday that it will host a webinar to provide an overview of the proposed program to stakeholders on 23 August 2017. OTC Monograph User Fees Dubbed OMUFA, short for the yet-to-be introduced Over-the-Counter M...