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Report: Internal FDA Report Slams European Regulation of Medical Devices as Ineffective

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The US Food and Drug Administration (FDA) has lambasted Europe's review process for medical devices in an unreleased internal report, claiming the failure of some devices to obtain FDA approval [Read More...]

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MHRA Advises Surgeons Against Using Some Metal-on-Metal Hip Implants

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The Medicines and Healthcare Products Regulatory Agency (MHRA) today (2 April) announced it is recommending surgeons “stop using a particular combination of metal-on-metal total hip replacements [Read More...]

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Researchers: Metal-on-Metal Hips Implants Should be Banned

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Researchers working with the world’s largest database on hip replacements have found so-called metal-on-metal hip implants are associated with high rates of failure, and recommended that they not be [Read More...]

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Australia’s Regulatory Body Takes Fire Over Medical Device Testing

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Australia’s Therapeutic Goods Administration (TGA) is taking fire from the Medical Journal of Australia (MJA) for a lack of medical device safety oversight, reports Fierce Medical Devices.MJA wrote 5 [Read More...]

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EC’s John Dalli Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices

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The European Commission’s (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to “look at the sector of medical devices as a whole,” saying that both the EC and national [Read More...]

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MHRA Appoints New Director of Medical Devices, Members to Pharmacopoeia

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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) appointed John Wilkinson, OBE, as the Director of Medical Devices at the agency on 8 February 2012.Wilkinson comes to MHRA from [Read More...]

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Duo of US Bills Aim to Prevent Drug Shortages, Amend 510(k) Pathway

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Representatives John Carney (D-DE) and Ed Markey (D-MA) both introduced bills this week that would, respectively, aim to prevent drug shortages and grant the US Food and Drug Administration (FDA) the [Read More...]

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New Safety Concerns About Metal-on-Metal Hip Implants Prompt MHRA Investigation

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) is announcing that it is launching a safety investigation in light of concerns that patients fitted with metal-on-metal hip [Read More...]

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Whistleblowers Accuse FDA of Monitoring Correspondence to Congress About Medical Device Concerns

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A group of former staff scientists at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) are accusing FDA of monitoring their interactions with Congressional [Read More...]

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MHRA Fires Back at The Lancet, Says Critics Lack "Clear Analysis of the Facts"

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Earlier this month, the British healthcare journal The Lancet published a series of scathing editorials that lambasted the medical device regulatory regimes of a number of European countries, and [Read More...]

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RAPS Scope of Practice Study: Tracking the Regulatory Profession 22 February 2012
UPDATED: EMA, AFSSAPS Call for Stricter EU Regulations on Medical Devices 6 January 2012
FDA: 99% of Establishment Registrations Now Electronic Post-FDAAA 13 January 2012

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