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Latest News | 3 May 2012

New French Regulatory Agency Announces Transition of Leadership

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France’s newly-formed National Agency for the Safety of Medicines and Health Products (MSNA), which will ostensibly replace Afssaps, announced 5 May that it will retain its existing leader, Dominique [Read More...]


Latest News Regulatory Update | 1 May 2012

France: New Agency to Soon Replace AFSSAPS

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France has created a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), to replace its current regulatory agency, Afssaps.The move was announced 29 April in [Read More...]


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...]


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...]


Latest News | 26 January 2012

PIP Executive Arrested in France, Could be Charged With Manslaughter

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Two former executives of the French company Poly Implant Prothese (PIP) were arrested on 24 January by French investigators, who may charge at least one of them with manslaughter for their role in a [Read More...]


Latest News | 6 January 2012

UPDATED: EMA, AFSSAPS Call for Stricter EU Regulations on Medical Devices

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European Medicines Agency (EMA) Executive Director Guido Rasi and French Health Minister Xavier Bertrand called on the EU to require medical device makers to go through a more rigorous approvals [Read More...]


Latest News | 4 January 2012

TGA: PIP Implants in Australia not Likely to Rupture

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The Australian Therapeutic Goods Administration (TGA) today released statements indicating that, “there is no evidence of an increased rupture rate for PIP [Poly Implant Prothese] silicone gel breast [Read More...]


Latest News | 2 January 2012

Reuters Analysis: Breast Implant Scandal Shows Shortfalls of Post-marketing Registries

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The Poly Implant Prothese (PIP) scandal raging across Europe right now highlights the failings of regulatory agencies to effectively use post-marketing registries, claims Reuters journalist Anna [Read More...]


Latest News | 28 December 2011

French Device Manufacturer Marketed Unapproved Device for Decades: Lawyer

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A French company under investigation for selling substandard silicone breast implants used unapproved industrial-grade silicone for implants, according to the company’s lawyer.  In an interview with [Read More...]