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  • Regulatory NewsRegulatory News

    EMA Sets Deadlines for 2016 Type I Variations

    The European Medicines Agency (EMA) on Monday said that marketing authorization holders (MAHs) need to submit any minor changes to drug marketing authorizations, also known as Type IA IN and Type IA variations, for 2016 by 30 November. MAHs are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations in 2016 by 13 December 2016. The deadlines have been set so that EMA can acknowledge the validity of the submissions before the age...
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    FDA Extends UDI Compliance for Certain Class II Devices

    The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices. In a letter to device labelers dated Tuesday, FDA said it is extending the UDI compliance dates for so-called device convenience kits and repackaged single-use devices and is clarifying the compliance date for device constituents for certain combination products. Under the UDI rule, FDA establ...
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    EMA to Revise Phase I Trial Guidance, Draft Expected in Late 2016

    The European Medicines Agency (EMA) on Thursday announced plans to update its guidelines on first-in-human (FIH) clinical trials following a trial incident in France last January that left one patient dead and five others hospitalized. The proposed revisions come after EMA launched a review of FIH trials in late May . At the time, EMA said its review would be based largely on the findings of two investigations into the fatal trial, which was conducted by French contra...
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    ANSM Committee Delves Into Nitty-Gritty of Fatal French Phase I Trial

    France’s National Agency for Medicines and Health Products Safety (ANSM) released a report this week outlining how its Temporary Specialist Scientific Committee (TSSC) evaluated what went wrong with a first-in-man clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January. ANSM launched its investigation into the Phase I trial in January, which the contract research organization (CRO) running t...
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    FDA to Require PMAs for Two Types of Hip Replacement Devices

    The US Food and Drug Administration (FDA) on Wednesday announced the issuance of a  final order  requiring manufacturers to submit a premarket approval (PMA) application for two types of metal on metal (MoM) total hip replacement devices. The new PMA requirement for the two types of devices -- the hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component -- comes as F...
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    First-in-Class, Rare Disease Drug Approvals Dominated in 2015: A Breakdown from FDA

    Last year was a banner year for the US Food and Drug Administration (FDA) in terms of new drug approvals, with many of the new drugs coming to market to help rare disease patients and offer new first-in-class options. The total of 45 approvals was well ahead of FDA’s average of about 28 novel approvals between 2006 and 2014, and 36% of those new approvals were for first-in-class drugs while almost half (47%) were to treat rare diseases, or ailments that impact 200,000 or...
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    Report: Competition Quickly Follows First-In-Class Approvals

    By the time "first-in-class" drugs receive marketing approval in the US, nearly all later iterations of those products have begun clinical testing or filed a new drug application with the US Food and Drug Administration (FDA), according to a new study by Tufts Center for the Study of Drug Development. The study, which compared 40 drug classes with a first-in-class approval between 1998 and 2011, found that the race for marketing approval for new classes of drugs and biol...
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    EMA Announces Sweeping Overhaul of Pediatric Class Waivers

    In a major move, the European Medicines Agency (EMA) announced today it is revoking or revising most product class waivers that allow companies to bypass the requirement to test new drugs in pediatric populations before they can be authorized. Background Companies are often reluctant to conduct clinical studies in children over ethical concerns and fear of adverse events occurring during trials. These reservations have created a gap in the number of products authorized ...
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    Sovaldi Patent Rejected in China Following Third-Party Challenge

    China's patent office has rejected a patent related to Gilead Science's blockbuster hepatitis C (HCV) drug Sovaldi. Background The rejection comes one month after the Initiative for Medicines, Access & Knowledge (I-MAK) filed several patent challenges against Gilead in China. I-MAK has also filed similar challenges in Argentina, Brazil, Russia and Ukraine, all citing Sovaldi's high price as a barrier to access in many middle-income countries where licensed generic ve...
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    FDA Provides New Guidance on Whole Slide Imaging Devices

    New draft guidance issued by the US Food and Drug Administration (FDA) offers a high-level roadmap for developers of digital imaging devices known as digital pathology whole slide imaging devices. As explained by FDA in the guidance and elsewhere on its website, the devices are used to convert analog microscope images into digital images, making it easier to diagnose patients without the use of a microscope. The devices generally consist of a larger system of devices (ca...
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    FDA Says it Will Regulate Robotic Exoskeletons

    The US Food and Drug Administration (FDA) has confirmed it will regulate all powered exoskeletons—a type of device intended to help paralyzed patients regain the ability to walk—as moderate-risk devices subject to a minimal level of premarket review. Background FDA's announcement comes as little surprise to close industry watchers. In December 2014, FDA notified exoskeleton manufacturer Ekso Bionics that its "Ekso" bionic suit would be subject to premarket controls. As...
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    British Regulators Launching Online Registration System for Low-Risk Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on 11 February 2015. The new  Devices Online Registration System (DORS)  will facilitate online registration of Class I devices, as well as cu...