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  • Regulatory NewsRegulatory News

    Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices

    A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death. The analysis, published in Nature Biomedical Engineering on Friday, raises questions about the trade-offs between speeding access to new devices and ensuring their safety. Specifically, the authors looked at the number of adverse events reported to the ...
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    EMA Revises Clinical Data Publication Guidance, Updates on Program

    The European Medicines Agency (EMA) on Friday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect in October . Revised Guidance The revision updates the previous version released in March , which clarified the agency's expectations for the data required to submit for publishing under the agency's clinical trial transparency rules. EMA says it has updated the section on the guidance's sc...
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    FDA Warns Specialty Pharma Company Over Adverse Event Reporting

    The US Food and Drug Administration (FDA) sent a warning letter to Langhorne, Pennsylvania-based STI Pharma LLC for failing to meet the agency's requirements for adverse event reporting. FDA sent the warning letter following an inspection on 21 July 2016, during which FDA says it found the company lacked written procedures for gathering, evaluating and reporting postmarketing adverse drug experiences (PADE), which are required under federal regulations. "Given your reli...
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    European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System A senior politician overseeing the United Kingdom’s exit from the European Union has dismissed the need to retain certain aspects of the country’s current regulatory model post-Brexit. Asked in the House of Commons whether he agreed with industry leaders on the need for the UK to be part of a Europe-...
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    Device Reporting Requirements for Manufacturers: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Monday finalized guidance to help device manufacturers meet the reporting and recordkeeping requirements for adverse events and malfunctions. The 52-page question-and-answer-based guidance, first drafted in July 2013, supersedes that draft and other guidance from 1997. “The goal is to detect and correct problems in a timely manner,” FDA said on Monday. “This guidance updates FDA’s policy and clarifies FDA’s interpretations ...
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    Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia . CFDA Posts Draft Medical Device Adverse Event Monitoring Guidance China’s Food and Drug Administration (CFDA) has posted draft guidance on post-marketing supervision of medical devices. The guidance sets out the role regional and national regulators, medical device manufacturers and adverse event monitoring technology institutions will play in tracking the safety of...
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    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. ...
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    Regulatory Misconduct: FDA Launches Website for Allegations Against Device Manufacturers

    A little more than a week after a scathing report in the Minneapolis Star-Tribune revealed the US Food and Drug Administration (FDA) has accepted late adverse event reports from device companies for hundreds of thousands of incidents, and the agency on Monday launched a new website for regulatory misconduct allegations. The webpage, Allegations of Regulatory Misconduct , allows anyone to submit a claim (via a new, simplified online form ) if it is believed that a me...
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    FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation

    The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing failures of the hospitals to report medical device-related adverse events. Several high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital , for their failure to keep written medical device reporting procedures and to repo...
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    HHS Looks at New Ways to Track Adverse Events Linked to Anticoagulants, Diabetes Drugs and Opioids

    The US Department of Health and Human Services (HHS) on Wednesday proposed six new inpatient and outpatient measures to track as part of efforts to reduce adverse drug events (ADEs) from anticoagulants, diabetes agents and opioid analgesics. Based on input from the Federal Interagency Workgroups for Adverse Drug Events, the six national measures and targets for the reduction of ADEs are being proposed in line with the ADE Action Plan from 2014. The primary ADE...
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    Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices

    The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday, with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs. The call for more compulsory license...
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    FDA Signs Off on Bayer Study of Essure Following Numerous Adverse Events, Deaths

    The US Food and Drug Administration (FDA) on Friday approved Bayer’s updated postmarket surveillance study plan for its permanent birth control device Essure, which has been linked to four adult deaths, 15 incidences of pregnancy loss and 631 reports of pregnancies in patients with Essure. Although FDA has not pulled the device from the market, in February the agency required Bayer to add a boxed warning to the device and to conduct a surveillance study. From 4 Nov...