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  • Regulatory NewsRegulatory News

    IMDRF Consults on Use of Registries to Support Device Approval Decisions

    The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making. Background Registries, which can capture outcomes associated with medical device use, were identified by IMDRF in 2014 as having "a significant gap" in optimal use for regulatory decision making. This gap led to the creation of IMDRF Registry Working Group ...
  • Regulatory NewsRegulatory News

    Industry Weighs Integration of UDIs Into Medical Device Registry Network

    The Advanced Medical Technology Association (AdvaMed) is at odds with a government task force over how unique device identifiers (UDI) could be used in a proposal for a coordinated registry network for medical devices. Background In 2012, the US Food and Drug Administration (FDA) issued a report, Strengthening Our National System for Medical Device Postmarket Surveillance , which detailed the agency's vision for improving device surveillance. One of the report's...
  • Regulatory NewsRegulatory News

    India Proposes eSubmission Process for Clinical Trials

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) has published a proposal to create an information technology (IT) system that would permit the online submission of information on clinical trials by sponsors, clinical research organizations (CROs), investigators, e...
  • Regulatory NewsRegulatory News

    Nuclear Regulators Ease Burden on Some Medical Devices, Expediting New Trials

    Sponsors of medical device products containing radioactive material may soon find it easier to bring the products to market under a newly proposed rule issued this week by the Nuclear Regulatory Commission (NRC). The rule, Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments , is an update to a 2002 rule on the medical use of so-called "byproduct material." According to the NRC, byproduct materials are tho...
  • 2012: The Year of the Patient Registry?

    • 13 December 2012
    • By
    Patient groups, regulatory agencies and companies are increasingly finding use in the establishment of patient registries-databases of patient data usually specific to a particular disease, and often including genetic, health, demographic and other information. One of the earliest adopters of the registry model was the Cystic Fibrosis Foundation , which established a registry in the early 1970s to better assess information about the relatively small number of patients l...
  • Japan Launches Implantable Device Post-Marketing Project

    Japan's Pharmaceutical and Medical Device Agency (PMDA) has launched J-MACS (Japanese Registry for Mechanically Assisted Circulatory Support), a data-collection project on the post-marketing experience with ventricular assist devices (VAD). The system, said regulators, is intended to be the first step in developing a new national system for collecting and evaluating data on the post-marketing experience with implantable medical devices. The project is a collaborative ...
  • NIH Launches New Registry for Down Syndrome Patients

    • 29 October 2012
    • By
    The US National Institutes of Health (NIH) has announced the establishment of a new patient registry for patients with Down syndrome, part of an effort to "facilitate contacts and information sharing among families, patients, researchers and parent groups." The registry could eventually have powerful research applications and regulatory significance. A similar registry operated by the Cystic Fibrosis (CF) foundation has been a driving force in product development, and ...
  • FDA Looks to Establish Patient Registry to Assess Risks of Imaging Contrast Agents

    • 17 July 2012
    • By
    The US Food and Drug Administration (FDA) has announced its intent to establish a new patient registry to assess the postmarketing risks of several contrast agents used in magnetic resonance imaging and angiography (MRI/MRA). In an 18 July posting in the Federal Register , FDA noted six of the eight gadolinium-based contrast agents (GBCAs) used in MRIs and MRAs are associated with nephrogenic systemic fibrosis (NSF)-a condition that causes excessive connective tissue ...
  • AHRQ Looking to Establish Registry of Patient Registries

    • 30 April 2012
    • By
    The US Agency for Healthcare Research and Quality (AHRQ), the federal agency charged with improving how healthcare dollars are spent, is announcing its intention to launch a registry of patient registries modeled after of its website. AHRQ explains in its Federal Register posting that patient registries, typically run by disease-specific foundations, have "specific characteristics" that the website has not been able to adequately c...
  • EU Looks to Tighten Medical Device Safety With Implant Registry

    The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, reports Fierce Medical Devices . "These proposals include the creation of breast implant registers, product traceability and a pre-market authorization system--among other items--to prevent future such episodes involving implantable devices," wrote Fierce . A Committee withi...
  • Clinical Trials Register Information for EU Now Available Through WHO

    The European Medicines Agency (EMA) announced this week it is making the EMA-managed EU Clinical Trials Register (EU-CTR) immediately made available and accessible through the World Health Organization's International Clinical Trials Registry Platform (ICTRP), adding a prominent registry to a growing number of international bodies. "The availability of the register on the WHO ICTRP platform provides wider access to the information contained in the registry and contr...
  • Feature ArticlesFeature Articles

    Regulatory Intelligence Tools I Cannot Live Without

    As someone who is passionate about regulatory intelligence (RI) and conducts trainings on the topic, I am often asked what my favorite tools are, which ones I would recommend (and which ones I would recommend against), what are the advantages of certain tools and how to do more with less. So, I have created a list of my top five tools. The tools you may have are dependent upon the type of company you work for and whether the leadership recognizes the value and competiti...