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Latest News | 6 February 2012

GAO Blasts 'Lack of Price Transparency' for Implantable Medical Devices

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A study  conducted by the US Government Accountability Office (GAO) on 3 February highlights price obfuscation that has ultimately increased prices for consumers receiving implantable medical devices [Read More...]

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Latest News | 6 February 2012

OIG: Oversight of Drug, Device, Clinical Trial Safety One of Their ‘Top Challenges’

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The Office of the Inspector General (OIG) of the US Department of Health and Human Services is calling the “oversight of the approval, safety and marketing of drugs and devices” one of their “top [Read More...]

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Latest News | 6 February 2012

Proposed Bill Would Limit Use of Consent Decrees, Settlement Agreements

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A bill introduced in the US House of Representatives by Reps. Ben Quayle (R-AZ), Dennis Ross (R-FL) and Howard Coble (R-CA) would place “limitations on consent decrees and settlement agreements by [Read More...]

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Latest News | 6 February 2012

FDA Releases New Draft Guidance on Positron Emission Tomography Products

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The US Food and Drug Administration (FDA) released new draft guidance for industry on 3 February that covers the regulation of positron emission tomography (PET) drugs. The guidance is intended to [Read More...]

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Latest News | 3 February 2012

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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Latest News | 3 February 2012

EC Investigation of PIP Implants Inconclusive, Calls for Further Study

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A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP’s breast [Read More...]

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Latest News | 3 February 2012

Reuters: French Regulatory Authority, Executives Searched In Mediator Probe

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The offices of French regulatory authority Afssaps were searched by French investigators on 2 February as part of an investigation in to deaths associated with Servier’s anti-diabetes drug Mediator, [Read More...]

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Latest News | 2 February 2012

Australia and New Zealand Agencies Announce Workflow Ahead of Planned Merger

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Australia’s Therapeutic Good Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority will be merged in to a single regulatory body in the next five years, according to a [Read More...]

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Latest News | 2 February 2012

GHTF Releases Proposed Changes to SG5 Clinical Performance Studies for IVDs

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The Global Harmonization Task Force released a new proposed document for their Study Group 5 (SG5) category called “Clinical Performance Studies for In Vitro Diagnostic Medical Devices.” The document [Read More...]

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Latest News | 2 February 2012

EMA Prepares for ‘Biggest Change’ to Legal Framework Since Founding

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The European Medicines Agency (EMA) announced on 2 February that it “is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change [Read More...]

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