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    FDA Warns Against Using Implanted Pumps With Unapproved Drugs

    The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid with drugs they were not approved for use with.   Using drugs that have not been approved for compatibility with the pumps could lead to dosing errors, pump failure, opioid withdrawal, infection, fever, vomiting, muscle spasms, cognitive changes and cardiac or respiratory distress, FDA says.   “The...
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    Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

    Medtronic and Monteris Medical are suggesting procedural techniques to reduce unintended thermal damage linked to their magnetic resonance-guided laser interstitial thermal therapy devices, the US Food and Drug Administration (FDA) said Thursday.   The agency summarized the new information from both medical device manufacturers and provided updated recommendations in two letters to health care providers. Medtronic issued three advisory letters between June and August t...
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    Pfizer and Mylan Report EpiPen Label Defect Could Delay, Prevent Emergency Use

    The US Food and Drug Administration (FDA) recently issued a safety alert to inform that EpiPen manufacturer, Pfizer, has become aware that the label sticker on certain auto-injectors “may have been improperly applied, causing resistance when removing it from the carrier tube.”   The safety alert affects Mylan’s EpiPen 0.3 mg and EpiPen Jr 0.15 mg containing labeled expiries on both the devices and cartons between June 2018 and February 2020 and between October 2018 a...
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    Alcon’s CyPass Market Withdrawal Escalates to FDA Class I Recall

    A US Food and Drug Administration (FDA) safety communication was escalated to a Class I recall for Alcon’s CyPass micro-stent systems over risk of eye damage in implanted patients.   FDA’s safety communication was issued last month based on a preliminary review of five-year post-surgery data from the COMPASS-XT study conducted by Alcon, the eye care division of Novartis. A second FDA safety alert involving the CyPass device was issued Wednesday in conjunction w...
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    New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety

    A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms. The study, conducted by researchers at Harvard Medical School, Northeastern University, Boston Children's Hospital and The Ohio State University, and funded by FDA's Center for Drug Evaluation and Research, looks specifica...
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    Reps Question Gottlieb on Bayer's Follow-Up Essure Studies

    Reps. Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) on Monday sent a letter to FDA Commissioner Scott Gottlieb regarding concerns related to Bayer's postmarket study for its permanent birth control device Essure. A year and a half after Bayer's postmarket study was initiated, "It is unclear whether Bayer acted with urgency to enroll patients, or if the study results will be delayed. The FDA cannot continue to allow Bayer to drag its feet on...
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    Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds

    The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found a higher association with these expedited pathways and the likelihood of safety-related labeling changes than with non-expedited pathways. In their analysis of 15 years of data, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Program on Regulation, Therapeutics, And Law...
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    ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

    The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection. ICH says the goal of the guideline, referred to as ICH E19, will be to provide "harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemen...
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    EMA Updates Guidance on Three Post-Authorisation Activities

    The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations. "The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes," EMA writes. Specifically, the updates include a new pre-submission c...
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    EMA Offers New EudraVigilance Checklist for Sponsors, MAHs

    The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017. The checklist features general testing instructions and easy-to-follow steps to assist sponsors and MAHs in the transition. In addition, EMA notes that the ICH E2B(R3) Implementation Guide and the EU ICSR Implementation...
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    Significant Safety Events Found in a Third of FDA-Approved Drugs, Study Finds

    Among 222 novel therapeutics approved by the US Food and Drug Administration (FDA) from 2001 through 2010, 32% were affected by a postmarket safety event, according to a study published in JAMA on Tuesday. Biologics, psychiatric therapeutics and those receiving accelerated approval and near–regulatory deadline approval were statistically significantly associated with higher rates of events, the study found. Of the 222 new drugs and biologics assessed, the study f...
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    EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research

    The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating that, when alternatives do not exist, the appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for pharmaceutical safety assessments. The opinion is part of a process to reevaluate the same conclusion from 2009 that “recognised that animals s...