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    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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    MDUFA V negotiations press on with breakdown over TPLC proposal

    In the latest negotiation session for the upcoming Medical Device User Fee Amendments (MDUFA V) program, the US Food and Drug Administration (FDA) and industry groups diverged over the agency’s ambitions for the next five-year program and the industry’s desire to lock-in gains from past programs.   TPLC Advisory Program   During the previous meeting on 7 April, FDA presented its vision for a Total Product Lifecycle (TPLC) Advisory Program (TAP) to a skeptical indus...
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    MDUFA V: FDA proposes TPLC advisory panel, industry says ‘back to basics’

    Minutes from the latest round of negotiations between the US Food and Drug Administration (FDA) and industry around the next iteration of the Medical Device User Fee Amendments (MDUFA V) have been released to the public and highlight how stakeholders are approaching the talks with different goals in mind.   Negotiations for MDUFA V began this year after months of delays due to the COVID-19 pandemic. Last year, a public kick-off meeting was pushed from April 2020 to Oct...
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    Shuren updates on inspections, ISO 13485 and MDUFA V

    Long delayed — even before the COVID-19 pandemic — the US Food and Drug Administration’s (FDA) proposed rule to harmonize its medical device Quality System Regulation (QSR) with the international standard, ISO 13485:2016, may finally see the light of day this year.   The much-anticipated proposed rule has been on FDA’s regulatory agenda for several years, and despite COVID-related delays, it is back on track, Jeff Shuren, director of the Center for Devices and Radiolog...
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    MDUFA V: Deficiency letters, staffing and funding emerge as issues in early negotiations

    After a delayed start, the US Food and Drug Administration (FDA) released minutes from the first two meetings held with the medical device industry to negotiation the terms of the next Medical Device User Fee Amendments (MDUFA V) program.   FDA and industry had originally planned to kick off the MDUFA V negotiations with a public meeting last April, but the meeting was delayed by six months due to COVID-19. (RELATED: MDUFA V: Industry wants fine tuning while FDA se...
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    GDUFA III: Use MDUFA model to create competition in generic drug markets

    As negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA) continue, stakeholders should consider a new financial model to improve equity and competition in generic drug markets, according to a recent Health Affairs blog post.   GDUFA was enacted in 2012 and reauthorized in 2017 as GDUFA II with the goal to “supplement FDA funds to expedite generic drug approval and inject competition in generic drug markets,” Margaret M. Dotzel, attorney and fo...
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    FDA calls for stakeholders to join MDUFA talks

    The US Food and Drug Administration (FDA) on Thursday called for non-industry stakeholders, including patient and consumer advocacy groups, to declare their interest in participating in consultation meetings for the next iteration of the Medical Device User Fee Amendments (MDUFA V) by 26 February 2021.   The monthly consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin next month. “FDA believes that consistent...
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    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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    MDUFA V: Industry wants fine tuning while FDA seeks expansion

    The US Food and Drug Administration (FDA) kicked off the negotiation process that will inform the fifth iteration of the Medical Device User Fee Amendments (MDUFA V) program via a virtual public meeting on Tuesday.   The meeting, initially scheduled to take place in April, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s medical device program from FY2023-FY2027.   During the meeting, FDA officials...
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    FDA Addresses Questions on 510(k) Third-Party Review Program

    The US Food and Drug Administration (FDA) recently responded to several comments related to a 2018 draft guidance on its 510(k) third-party review program, which was crafted because of the latest reauthorization of the Medical Device User Fee Act . The third-party review program is intended to allow for the review of devices by certain outside organizations to provide manufacturers of lower risk devices with an alternative review process that allows FDA to best utilize...
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    CDRH Works on Clinical Objectivity in Patient-Reported Outcomes

    A new study conducted by mathematical statisticians at the US Food and Drug Administration (FDA) bridges the gap between an objective endpoint and a patient-reported outcome (PRO). The research , led by statisticians Chul Ahn and Xin Fang at FDA’s Center for Devices and Radiological Health (CDRH), seeks to arrive at an acceptable level of probability for a PRO measure to reveal the “truth” of a subject’s disease or health condition. It comes at time when the science of ...
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    FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

    The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV). In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a n...