• Regulatory NewsRegulatory News

    Burr chastises FDA at second Senate user fee hearing

    Sen. Richard Burr (R-NC) continued to criticize the US Food and Drug Administration (FDA) for failing to provide lawmakers a Medical Device User Fee Amendments (MDUFA V) deal and for not publishing meeting minutes with industry on time. His comments came during the second user fee reauthorization hearing in the Senate Health, Education, Labor and Pensions (HELP) committee.   On 26 April, the directors of FDA’s medical product centers sat before the HELP committee to ...
  • Regulatory NewsRegulatory News

    Shuren apologizes for MDUFA delay, says FDA will start closing the spigot on new EUAs

    The head of the US Food and Drug Administration’s (FDA) device center was criticized by top House lawmakers for not getting a Medical Device User Fee Amendments (MDUFA V) deal to them for review on time. He apologized for missing the statutory deadline and noted his staff have been slammed due to the COVID-19 pandemic.   On 30 March, the House Energy and Commerce (E&C) subcommittee on health met to discuss renewing FDA’s MDUFA program . At the start of the meeting c...
  • This Week at FDAThis Week at FDA

    This Week at FDA: MDUFA’s turn in Congress, another COVID vaccine adcomm, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we learn that the House Energy and Commerce committee will finally take up legislation to reauthorize the Medical Device User Fee Amendments (MDUFA) next Wednesday. Plus, we look at upcoming developments on COVID-19 vaccines and a much-anticipated advisory committee meeting o...
  • Regulatory NewsRegulatory News

    MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more

    The new medical device user fee deal includes the US Food and Drug Administration’s (FDA) total product lifecycle (TPLC) advisory program, or TAP, as well as new guidance development requirements and claw back provisions that let industry renegotiate fees. If signed into law as is, it would bring in $1.78-$1.9 billion over the next five years.   FDA finally published a commitment letter on 22 March summarizing the Medical Device User Fee Amendments (MDUFA V) deal i...
  • Regulatory NewsRegulatory News

    MDUFA V: We have a deal

    Updated 11 March 2022 to clarify ACLA's role in the MDUFA negotiations. The US Food and Drug Administration (FDA) and medical device industry groups have finally struck a user fee deal after a two-month delay, sources with intimate knowledge of the negotiations tell Regulatory Focus . The deal states the FDA will receive $1.784 billion in user fees over the next five years but that number could go up to $1.9 billion if the agency meets all its performance goals.   ...
  • Regulatory NewsRegulatory News

    User fee reauthorization process kicks off in Congress

    The House Energy & Commerce health subcommittee on Thursday held the first hearing in the process to reauthorize the US Food and Drug Administration’s user fee programs for human drugs and biosimilars.   Top FDA officials Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), testified to the success of the agency’s current user fee programs and on the e...
  • Regulatory NewsRegulatory News

    Lawmakers press Woodcock for MDUFA update

    Leaders from the House and Senate health committees wrote to Acting FDA Commissioner Janet Woodcock on Friday after the agency missed the 15 January deadline to transmit the commitment letter for the next iteration of the Medical Device User Fee Amendments (MDUFA V) to Congress.   The letter, signed by Senate Health, Education, Labor and Pensions committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC), as well as House Energy & Commerce committee C...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...