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    EC Offers New Site Suitability Template Under Incoming Clinical Trial Regulation

    The European Commission (EC) on Tuesday published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which has yet to take effect. The template was developed and endorsed by the EU Clinical Trials Expert Group on 9 October to comply with the new regulation, known as Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use. “However, this templat...
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    Rare Disease Clinical Trials: FDA Awards $15M in Grants

    After receiving 89 clinical trial grant applications, the US Food and Drug Administration (FDA) on Tuesday selected 12 projects that will be funded with more than $15 million over the next four years.   The announcement of the new funding comes as approximately 30 million Americans are affected by 7,000 known rare diseases, but only a few hundred treatments exist for these rare diseases.  Two-thirds of the 2019 grants will go to studies affiliated with universities,...
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    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...
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    Health Canada’s Public Release of Drug, Device Clinical Data Picks Up Steam

    Last March, amendments to Canada’s  Food and Drug Regulations and the Medical Devices Regulations enabled the public release of clinical information submitted to Health Canada for new drug and device approvals. But in the first five months after the amendments took effect, just one clinical trial package for a new drug and one clinical trial package for a new device were published. In the last two months, however, Health Canada has published information on eight more d...
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    Survey From CDRH Officials Finds Informed Consent Process Needs Improving

    Informed consent forms (ICFs) may meet the necessary regulatory requirements but are often not written in a way to promote comprehension among clinical trial participants, a new research article from six officials in the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) found. The officials surveyed 399 ICFs from investigational device exemption (IDE) applications for fiscal years 2015 and 2016, finding that overall, the ICFs were...
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    New Research Questions FDA’s Reliance on and Inability to Enforce Postmarketing Requirements

    As the US Food and Drug Administration (FDA) has increasingly relied on postmarketing requirements (PMRs) to support its approval decisions, a new study published in the Milbank Quarterly discusses how FDA’s lack of ability to enforce PMRs reveals an agency “on guard against a set of larger political threats to its mandate.” The study’s publication follows a recent report from FDA showing that most of the required PMRs and voluntary postmarketing commitments (PMCs) ...
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    FDA’s Woodcock Weighs in on Role of NIH in Drug Development

    US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday that while the National Institutes of Health (NIH) has been instrumental to drug discovery and development, she does not think NIH or academics should be in the business of developing new pharmaceuticals. The comments came as part of the first day of a two-day meeting at the National Academies of Sciences, Engineering and Medicine in Washington, DC...
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    FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.   “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibi...
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    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...
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    Health Canada Implements ICH Guideline on Good Clinical Practice

    Health Canada said Wednesday that it has implemented the International Council for Harmonisation’s (ICH) guideline on good clinical practice, known as E6(R2). While working to eliminate the differences between its own and ICH guidances, Health Canada said that in cases of such discrepancies, Health Canada-implemented ICH guidances should take precedence. The decision to implement the guideline in Canada follows the work of its ICH peer regulatory agencies to implemen...
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    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 ...
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    HMA Offers Recommendations on Complex Clinical Trials

    A subgroup of the EU’s Heads of Medicines Agencies (HMA) issued new recommendations Friday on conducting complex clinical trials.   The HMA’s Clinical Trials Facilitation Group (CTFG)—coordinated by the Danish Medicines Agency—identified eight key recommendations to establish a framework on the initiation and conduct of complex trials for the development of personalized medicine. They were prepared “in recognition of the fact that the development of personalized medici...