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    Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds

    Two safety communications issued by the US Food and Drug Administration (FDA) had different impacts on the use of surgical mesh to treat pelvic organ prolapse (POP), according to a recent study appearing in JAMA Internal Medicine . The first look at the use of surgical mesh in New York between 2008 and 2011 found that use actually increased after FDA's first safety communication, from 21% of all procedures in 2008 to 30% in 2011. However, the use of surgical mesh later ...
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    FDA to Release ‘Emerging’ Safety Info on Devices

    As the US Food and Drug Administration (FDA) looks to catch signals of medical device safety issues earlier to prevent adverse events, the agency has put out draft guidance outlining how it will track and release such information publicly. The release of the new information -- for concerns that have yet to be fully analyzed, validated or confirmed by the agency -- will come in addition to the recall notices, safety communications and press releases that the agency alread...
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    FDA Offers Draft Guidance on IND Safety Reporting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 ...
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    FDA to Release Major Generic Drug Labeling Rule in July 2016

    The US Food and Drug Administration (FDA) has now said it will release in July a controversial and major final rule that would allow generic drug companies to update their labels with new safety information like their reference product counterparts have done for almost 30 years. Background Under current FDA regulations, generic drug companies with abbreviated new drug applications (ANDAs), unlike companies with new drug applications (NDAs) and biologics license applicat...
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    CDRH Unveils Top Regulatory Science Priorities for 2016

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday. The release of the list coincides with the overarching goal of CDRH regulatory science, which is to help develop and apply tools, standards and methodologies to study the safety, eff...
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    EMA Updates Two Pharmacovigilance Guidelines

    Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU. The two guidelines include a draft version of Module VIII – Post-Authorisation Safety Studies (Rev 2) , which is expected to come into effect in early 2016, and Module IV – Pharmacovigilance Audits (Rev 1) , which takes effect on 12 August 2015. Background Pharmacovigilance is the process of monitoring the use...
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    EMA Hopes to Boost Drug Safety in Scientific Advice Pilot

    In an effort to boost the safety of approved drugs, the European Medicines Agency (EMA) is piloting a new procedure that would allow companies to seek the agency's advice on designing post-authorization safety studies (PASS). Background Currently, EMA and its Scientific Advice Working Party (SAWP) offer scientific advice to companies developing medicines. The advice is primarily intended to help drugmakers design "trials that are scientifically sound and generate rob...
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    How Often Does FDA Withdraw Drugs Using Discontinuation Petitions? Very Rarely

    Not all drugs approved by the US Food and Drug Administration (FDA) stand the test of time. In some cases, the drugs are eventually removed from the market, either because they are unsafe, ineffective or just because their sponsor no longer feels like making them. But how often do these withdrawals take place, and to what extent do they reflect concerns about the safety or efficacy of a drug? Background The question is the subject of a new analysis by Hyman, Phelps & Mc...
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    EU's New Centralized Pharmacovigilance Portal Gets Endorsement from EMA

    A year from now, drugmakers in the EU will be required to submit postmarket safety reports to an online central repository, the European Medicines Agency (EMA) has confirmed. Background In January 2015, EMA announced the launch of a central repository , hosted on the eSubmissions website, for submitting periodic safety update reports (PSURs). In the EU, drugmakers are required to submit PSURs to EMA at regular intervals. These reports are evaluated and used to en...
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    EMA Issues Recommendations for Veterinary Pharmacovigilance, Signal Detection

    The European Medicines Agency (EMA) has released a new set of recommendations for postmarket surveillance for veterinary medicinal products, which will go into effect on 1 October 2015. Background Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. For veterinary populations, regulators, companies and veterinarians are responsible for monitoring drugs and reporting suspected adverse drug reactions (ADRs). This information ...
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    EMA Adopts New Guideline on Urine-Derived Product Safety

    The European Medicines Agency (EMA) has adopted a new guideline on the regulatory requirements for ensuring the viral safety of urine-derived medicinal products. Background Human urine is an essential component in certain hormone-based treatments and some products used to break up blood clots. Products derived from human urine have been available in Europe since the 1970s. While numerous improvements have been made to ensure the safety and purity of these products, spe...
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    WHO Makes Drug Side Effects Easier to Find With New Database

    Last week, the World Health Organization (WHO) boosted its transparency efforts with the launch of a new, open access drug safety database called VigiAccess. Background The practice of postmarket drug monitoring, or pharmacovigilance, is an important part of ensuring patient safety after a product has been approved. During clinical trials, it is not possible to determine every possible side effect or reaction to a drug or vaccine. By monitoring drugs and collecting re...