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  • Regulatory NewsRegulatory News

    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.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have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...
  • Regulatory NewsRegulatory News

    Study: RWD not ready for postapproval prime time

    For drugs and biologics that receive accelerated approval, could information drawn from real-world data sources supplant traditional postapproval clinical trials to confirm that the therapies have benefit? Real-world data (RWD) are not yet robust enough to confirm the benefit of drugs awarded accelerated approval based on surrogate endpoints, answered the authors of a recent study.   “The findings of this cross-sectional study suggest that none of the 50 [Food and Drug...
  • Feature ArticlesFeature Articles

    China’s data localization‒centric policies and their impact on human research

    This article reviews Chinese laws governing healthcare data and genomic resources during 1998-2021 and their impact on clinical research in humans by pharmaceutical companies. Companies conducting such research must be vigilant about complying with the complex legal requirements governing the research and identifying potential risks and mitigation strategies for compliance. The analysis includes review of various legal requirements issued by the People’s Republic of China ...
  • Regulatory NewsRegulatory News

    EU clinical trial portal and database declared functional

    The European Medicines Agency (EMA) announced that its long-delayed EU clinical trial portal and database are fully functional, paving the way for the launch of the EU Clinical Trial Information System (CTIS) and the application of the EU Clinical Trial Regulation early next year.   The CTIS was originally expected in September 2018; however, a series of delays have pushed back the launch date for the system, and the EU Clinical Trial Regulation it is intended to suppo...
  • RF Quarterly

    RF Quarterly, March 2021: Global clinical trials

    Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...
  • RF Quarterly

    Planning for a clinical trial application

    In recent years, global clinical trials have become standard, and for a good reason. In broad terms, expanding clinical trials across the world provides a better opportunity for demonstrating the true impact of an investigational drug. Global clinical trials offer key advantages to patients and industry, but smaller companies may be hesitant to participate in global trials, wondering if the inevitable challenges outweigh the benefits. The key considerations in designing a ...
  • RF Quarterly

    Modernizing clinical trial regulations in Canada

    This article provides an overview of Health Canada’s plans to modernize its clinical trials regulations and enhance health care agility in the regulatory framework for its health care products by making regulations more flexible and adaptive to innovation. The author discusses how clinical trials in several health care product lines can be modernized and looks at how lessons learned from the COVID-19 pandemic experience can help set up a more flexible regulatory framework ...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on complex innovative trials designs

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance for sponsors on interacting with the agency on complex innovative trial designs (CID) for drugs and biologics.   The nine-page final guidance comes just over a year after the draft version was released for comment and two years after the agency launched its CID pilot program. (RELATED: FDA launches pilot program in support of complex trial designs for drugs and biologics , Regulatory Focus 2...
  • Regulatory NewsRegulatory News

    BIO: What it takes to make the leap to decentralized trials

    Though there’s excitement and much promise in leveraging technology to meet participants on home turf, “We’re all still taking baby steps in bringing the clinical trial to the patient,” said Rasika Kalamegham, speaking of making the move to decentralized clinical trials. Moderating a decentralized trial-focused session at BIO Digital, she and other session participants discussed how to tease out where promise lies and what hurdles stand in the way of sponsors, regulators, ...
  • Regulatory NewsRegulatory News

    CDRH Warns Idaho Wheelchair Manufacturer for Unapproved Modifications

    The videos at 21 st Century Scientific’s website wheelchairs.com show people taking their wheelchairs off-road, in the sand and at high speeds. But the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told the Idaho-based company in a warning letter posted Tuesday that these modifications to their wheelchairs were never approved by the agency. “Use on these terrains and functions that enable the device to lift the user, tilt the...
  • Regulatory NewsRegulatory News

    Almost Half of All New Drug Approvals in 2018 Relied on One Clinical Trial

    Back in the 1970s and 1980s, the US Food and Drug Administration (FDA) made clear that at least two adequate and well-controlled studies were necessary to establish a new drug’s effectiveness, except in only the rarest of circumstances. Then in 1997, the Food and Drug Administration Modernization Act was passed, and Congress clarified that FDA may consider “data from one adequate and well-controlled clinical investigation and confirmatory evidence” to approve a new dr...
  • Regulatory NewsRegulatory News

    IMDRF Works to Speed Entry of Devices Across Multiple Countries

    The International Medical Device Regulators Forum (IMDRF) proposed updates on Wednesday to clinical evaluation documents in support of rapid market entry across multiple jurisdictions. The IMDRF’s medical devices clinical evidence working group (MDCE WG) re-issued consultations Wednesday to propose updates to three Global Harmonization Task Force (GHTF) documents from 2007 and 2010. The MDCE WG’s consultation documents seek to reflect the recently implemented and/or ...