• 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    FDA Offers Draft Guidance on IND Safety Reporting

    For investigational new drug application (IND) sponsors running clinical trials and debating when a serious adverse event can be linked to an investigational drug and is serious enough to unblind data, FDA offered new draft recommendations on Wednesday. The new guidance on IND safety reporting follows previous guidance on Safety Reporting Requirements for INDs and BA/BE Studies from 2012 and contains specific details on: The composition and role of a safety assessment ...
  • Regulatory NewsRegulatory News

    Tufts CSDD Raises Questions over Adverse Event Reporting in US

    Inconsistencies in the way adverse event reports are filled out and sent to the US Food and Drug Administration (FDA) could mislead drug safety professionals and cause the wrong conclusions to be drawn, in addition to myriad other issues, according to a report from the Tufts Center for the Study of Drug Development released Wednesday. Background FDA has three adverse event reporting forms it uses to collect data on drugs (prescription and non-prescription), biologics, m...
  • Feature ArticlesFeature Articles

    Managing Pharmacovigilance in Digital Health Initiatives

    • 14 August 2015
    This article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives. The pharmaceutical industry, most would agree, has been slow to embrace the use of digital technologies, such as the cloud and mobile devices, in delivering healthcare. As with social media, pharmaceutical company involvement in digital health presents many difficult questions, making executives uneasy. Among...
  • Regulatory NewsRegulatory News

    FDA and Google Talk 'Adverse Event Trending'

    Last month, representatives from the US Food and Drug Administration (FDA) and search giant Google met to discuss "adverse event trending," Bloomberg reports. Background Currently, FDA keeps track of adverse events submitted through voluntary and mandatory reports to its FDA Adverse Event Reporting System (FAERS). Drugmakers are required to report adverse events to the agency; however, patients and their doctors do so voluntarily, leading to serious underreporting. ...