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    Third time’s a charm: US FDA reissues cybersecurity draft guidance

    After significant stakeholder feedback, the US Food and Drug Administration decided instead of finalizing a 2018 premarket cybersecurity draft guidance, it would reissue a whole new draft guidance with significant changes. One of those changes includes asking manufacturers to provide a software bill of materials (SBOM) instead of a cybersecurity bill of materials (CBOM) which was a major sticking point for the medtech industry.   The FDA published the draft guidance ti...
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    FDA proposes framework for updated COVID vaccines to spur discussion

    The US Food and Drug Administration (FDA) has presented a framework to update the composition of COVID-19 vaccines based on new strains. During a meeting with its Vaccines and Related Biological Products Advisory Committee (VRBPAC), the agency said the framework is not final and only meant encourage discussion on how the agency can address the need to update vaccines for new antigenically distinct variants.   "The framework is tentative, it is thrown out to be placehol...
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    Marks calls for new gene therapy development paradigm

    The head of the US Food and Drug Administration’s (FDA) biologics center says the current drug development process is not well-suited for gene therapy products. He says there needs to be a total rethinking from clinical trial designs, statistical tools, manufacturing practices to global regulatory harmonization to get new gene therapies to patients more effectively.   Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), says there needs to ...
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    FDA’s legislative wish list includes device cybersecurity, a generic exclusivity fix, and more

    The US Food and Drug Administration (FDA) would receive new authorities under proposals in legislation introduced alongside the Medical Device User Fee Amendments (MDFUA V) reauthorization bill and in its FY2023 budget request. Those authorities include requiring medical device manufacturers to address cybersecurity, fixing a loophole with generic drug patent challenge exclusivity and clarification of the term medical device remanufacturing.   Over the past week, FDA...
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    FDA says IT modernization came at right time for COVID

    While the US Food and Drug Administration (FDA) began the process of modernizing its IT systems before the COVID-19 pandemic, the crisis accelerated much of that work and allowed the agency to streamline much of its activities at a critical moment in time, according to FDA Commissioner Robert Califf.   On 31 March, FDA published its Modernization in Action 2022 report that outlines how the agency’s efforts to modernize its IT systems have helped address the global ...
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    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...
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    FDA officials aim to stop misuse of the term ‘digital biomarker’

    While a lot of researchers claim they are capturing digital biomarker data, they may in fact be collecting clinical outcomes assessment (COA) data according to some US regulators. To clarify the differences, top US Food and Drug Administration (FDA) officials have defined digital biomarkers versus other kinds of data in a new article.   According to FDA officials in an article published on 25 March in npj Digital Medicine , a digital biomarker is “a characteristic o...
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    Stakeholders ask for more time to transition EUA devices, diagnostics

    Responding to two US Food and Drug Administration (FDA) draft guidances on transitioning products granted emergency use authorization (EUA) during the pandemic to regular marketing authorizations, key stakeholders raised concerns the agency isn’t providing enough time to collect the necessary data or make labeling changes after the current public health emergency (PHE) is over.   In December, FDA published two much-anticipated draft guidances titled, “ Transition Plan ...
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    Stakeholders want more clarity about devices used for remote clinical studies

    A number of stakeholders have written to the US Food and Drug Administration about the agency’s recent draft guidance on how digital health technologies (DHT) could be used to conduct clinical trials remotely. Some have concerns about the agency too narrowly defining what products can be used for remote monitoring, while others argue it’s not broad enough. Some are also asking the agency to include smart packaging in the guidance.   In December, the agency published i...
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    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...
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    Shuren: Let’s take regulatory flexibility beyond COVID-19

    Congressionally authorized regulatory flexibility could provide medical device manufacturers with more options and help the US Food and Drug Administration (FDA) better monitor product safety and efficacy, according to Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH).   “There really is a need for more flexibility to have agile regulation,” said Shuren during a fireside chat on 22 March at the Duke-Margolis Center for Health Policy’s d...
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    FDA seeks to streamline inactive ingredient database with industry input

    The US Food and Drug Administration (FDA) wants to know how it should prioritize maximum daily exposure (MDE) information and whether it should remove dosage form information from its inactive ingredient database (IID). The move is part of the agency’s commitment to industry to streamline the drug database.   On 21 March the FDA published a notice asking drug makers and other stakeholders what it should do to streamline the IID. As part of the generic drug user fee a...