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    FDA Classifies Post-Concussion Test

    Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices. In August, FDA cleared ImPACT Applications' Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices via its de novo classification pathway, as no similar devices had been previously cl...
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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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    FDA Warns 14 International Medical Device Companies

    The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines. By far the most common issues cited by FDA were: Number of Citations Issue 11 Failure to establish and maintain adequate procedures for imple...
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    FDA: Generic Opioids Must be 'No Less' Abuse-Deterrent Than Brand-Name Versions

    The US Food and Drug Administration (FDA) released a new draft guidance intended to ensure that generic versions of abuse-deterrent opioids meet the same standards for abuse deterrence as their brand-name counterparts for public comment on Thursday. The new draft guidance is part of a wider effort by FDA to address the national opioid epidemic, which claimed the lives of more than 28,000 Americans in 2014 . In February, the agency detailed its opioids action plan, sa...
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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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    Public Health Advocates Worry EMA and Industry are Too Cozy

    A coalition of health advocacy groups are worried that too much of the European Medicines Agency's (EMA) funding comes from private industry. Background Much like the US Food and Drug Administration (FDA), EMA receives much of its funding from fees it collects from industry for various services, such as application fees, scientific advice and pharmacovigilance fees. Generally, industry has been supportive of regulators charging fees for these services (although somet...
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    NIH Plots out Path Forward After Disastrous FDA Inspection

    • 22 June 2015
    The National Institutes of Health (NIH) says it is working quickly to figure out how to correct major deficiencies uncovered by the US Food and Drug Administration (FDA) last month at one of its drug compounding facilities. Background On 4 June 2015, NIH issued a statement saying it had "suspended operations" at its Pharmaceutical Development Section (PDS) following an inspection by FDA that found "a series of deficiencies." PDS is NIH's pharmaceutical development arm,...
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    How Should Regulators Warn Patients About New Drug Risks? UK Wants to Know

    In an effort to improve how safety issues are communicated, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey for healthcare professionals to provide input on how the communications are used. Background The survey is being launched as part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action initiative, which was launched to "help medicines regulators operate pharmacovigilance systems...
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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...