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    EMA to explore reviewing raw data from clinical trials in applications

    The European Medicines Agency (EMA) is looking for industry participants for a pilot assessing whether reviewing raw clinical trial data improves its evaluation of marketing authorization applications (MAAs) for new medicines and post-authorization applications.   The pilot , announced on 12 July, stems from a joint workplan announced by EMA and the EU’s Heads of Medicines Agencies (HMA) to address issues related to big data in healthcare and medicines development. On...
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    Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

    Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...
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    Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome

    Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...
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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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    Artificial intelligence in regulatory practice

    This article will examine ways in which the regulatory profession can draw artificial intelligence (AI) to navigate the complexities and fluidity of the global regulatory landscape. Keywords – artificial intelligence, big data, machine learning, SaMD   Introduction Many of the processes within the regulatory landscape entail gathering data, tabulating spreadsheets, collating documents for regulatory submissions, and reviewing dossiers to ensure their quality is c...
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    Device companies urge FDA to refine guidance on PCLC devices

    Medical devices companies urged the US Food and Drug Administration (FDA) to expand the scope of its recent guidance on assessing physiologic closed-loop control (PCLC) technology to cover non-invasive devices and to incorporate additional standards when outlining patient hazards.   Other companies suggested that FDA include additional examples of sensor performance risks.   The comments were in response to FDA’s draft guidance for manufacturers on developing med...
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    Industry cites outdated standards as flaw in FDA’s real-world data draft guidance

    The US Food and Drug Administration (FDA) should adopt updated data standards that accommodate the “evolving and emerging” nature of real-world data not currently reflected in the Data Standards Catalogue, according to industry comments on the agency’s draft guidance.   Overall, comments from industry generally supported the principles in FDA’s draft guidance on data standards for drug and biological products submissions containing RWD (RELATED: FDA drafts data sta...
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    FDA: Device breakthrough program surpassed expectations, while novel device authorizations fell in 2021

    In its 2021 annual report, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said that it cleared, approved or authorized a record 13 devices with breakthrough status, though the number of novel devices it authorized fell from its peak last year.   The report also discusses the center’s actions to address device shortages, thanks to new funding from Congress, as well as its COVID-19 pandemic response, patient engagement and d...
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    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...
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    Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More than 1 million Americans were diagnosed with COVID over the long holiday weekend ( NPR ) ( Reuters ) Elizabeth Holmes is found guilty of four counts of fraud ( NYT ) ( POLITICO ) The Epic Rise and Fall of Elizabeth Holmes ( NYT ) Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US ( Fierce ) CDER, CBER Approve Total...
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    This week at FDA: Medtronic MiniMed problems; Device classification flurry

    Welcome to 2021’s last issue of This Week at FDA. This week saw a year-end flurry of device classifications; we are also sharing news of three noteworthy device warning letters and a citizen petition response that closes with FDA’s referring a firm to the Federal Trade Commission (FTC) for anticompetitive practices.    RAPS offices are closed 23 December – 2 January. Regulatory Focus will resume publication on 3 January. From our team to you, our valued readers, best...