• Regulatory NewsRegulatory News

    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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    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...
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    Popular RAPS App Back Again for 2016 Regulatory Convergence

    If you will be attending RAPS’ Regulatory Convergence in San Jose next month, go download the RAPS Events app for your smart phone now. The app was unveiled for the first time at last year’s Convergence in Baltimore and it proved to be a runaway hit. Users found it useful, fun and intuitive. Last year, Convergence veterans and first-timers alike used the app to engage with one another, share photos, observations and takeaways from the sessions they attended ...
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    EMA Releases List of Medical Events for Pharmacovigilance Monitoring

    The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events. EMA says the list will assist it and other regulators to prioritize the review of suspected adverse events that "deserve special attention, irrespective of statistical criteria used to prioritize safety reviews," and contribute to the agency's day-to-day pharmacovigil...
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    European Regulatory Roundup: Novartis Faces MHRA Criticism on Trial Data Access (21 July 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Novartis Faces MHRA Criticism Over Access to Trial Data Novartis has revealed the Medicines and Healthcare Products Regulatory (MHRA) has criticized its UK operation following an inspection. The criticisms center on the systems Novartis’ UK unit uses to provide health authorities with access to trial data. Specifically, Novartis said MHRA inspectors were critical of t...
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    Swissmedic Sees Spike in Adverse Event Reports for Third Straight Year

    In a new report on its work in 2015, Switzerland’s drug and medical device regulator Swissmedic has seen a sharp rise in the number of suspected adverse drug reaction (ADR) reports received (7.1% increase from 2014 and a more than 30% increase from 2013), due mainly to an increased volume of reports from industry. “The number of follow-ups to ADR reports is now also being recorded as a big increase in the number of reports was observed during the year and they are labour...
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    FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

    The US Food and Drug Administration (FDA) again pushed back (from later this summer until April 2017) its finalization of a contentious rule that would allow generic drug companies to update labels like their brand name counterparts. An FDA spokeswoman told Focus that the new date for the finalized rule is a “projected” date “that may be adjusted to reflect ongoing work,” though she could not offer any specifics on why this date was pushed back for this rule. The pro...
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    CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday announced the availability of an electronic submission system for companies to submit adverse events linked to vaccines. The launch of the system, which is part of the Vaccine Adverse Event Reporting System (VAERS) run jointly by FDA and the Centers for Disease Control and Prevention, follows guidance released in August 2015 that offers recommendations on the ele...
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    CBER Calls on HCT&#47P Manufacturers to Report Adverse Events Within 15 Days

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Tuesday issued new guidance to provide establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable diseases. CBER notes that examples of HCT/Ps that are subject to adverse reaction reporting and fall with...
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    FDA Urges Caution With Neurosurgical Head Holders Due to Slippage

    The US Food and Drug Administration (FDA) issued a safety notice Thursday on the use of neurosurgical head holder (skull clamp) systems, which secure the patient’s head during surgical procedures. From January 2009 to January 2016, the agency said it received more than 1,000 medical device reports (MDRs) associated with the slippage or movement of a skull clamp before and/or during surgical procedures, resulting in more than 700 injuries, though the review did not find ...
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    RAPS DC-Baltimore Chapter Meets for Fun and Networking

    Despite warnings of a massive snow storm, members and guests of the RAPS DC/Baltimore Chapter gathered for an evening meet-up 21 January at Union Jacks pub in Bethesda, MD. As they arrived, people joined in a game to "find the D-RAP," with "D-RAP" meaning the designated regulatory affairs professional. Attendees simply had to talk to one another in order to play. Then they formed groups to discuss topics such as how regulatory professionals can distinguish t...
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    The Art of Saying Yes and No

    ‘Yes’ and ‘no’ are two simple words in the English language, but they generate a vast array of mind-boggling complexities when used incorrectly—whether intentionally or unintentionally. How many of us have said yes when we actually wanted to say—or should have said—no, and vice versa? Imagine you are invited to party you have no desire to attend, and inside you are screaming “no,” but you say yes because you do not want to offend the host or wish others to think y...