• 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

    Patient Registries: EMA Wants to Make Better Use of Medicines Data

    The European Medicines Agency (EMA) on Friday is hosting a workshop to discuss ways to better use existing patient registries that collect high-quality data on drugs in clinical practice. Patient registries collect information over time on patients with a particular disease or who receive particular treatment during both pre-authorization and post-authorization periods. Such data can complement data from other sources to more effectively monitor drug risks and benefits. ...
  • Regulatory NewsRegulatory News

    FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions. The 21-page draft document, which is open for comment for the next 90 days, also explains how the agency plans to evaluate real-world data to determine whether it may be sufficiently relevant a...
  • Regulatory NewsRegulatory News

    CDISC Unveils New Standard for Clinical Trial Registries

    • 09 May 2016
    The new standard from the Clinical Data Interchange Standards Consortium (CDISC) will help industry generate submissions for multiple, global clinical trial registries, particularly those from the World Health Organization (WHO), European Medicines Agency (EMA) and ClinicalTrials.gov from a single file. The standard, known as the Clinical Trial Registry (CTR) XML, is inspired by the International Committee of Medical Journal Editors (ICMJE), and is based upon the 2...
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    EMA Sets Up Two-Year Pilot Program on Patient Registries

    The European Medicines Agency (EMA) has launched an initiative focused on existing patient registries, with the aim of seeing how they can be better used as a source of post-authorization data, and how they can help to establish new registries. Background EMA defines a registry as a system using observational methods over time to collect uniform data on a population defined by a particular disease, condition, or exposure. A disease registry includes patients bas...
  • AHRQ Looking to Establish Registry of Patient Registries

    • 30 April 2012
    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 ClinicalTrials.gov website. AHRQ explains in its Federal Register posting that patient registries, typically run by disease-specific foundations, have "specific characteristics" that the ClinicalTrials.gov website has not been able to adequately c...