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Latest News
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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
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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
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Latest News
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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,
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Latest News
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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
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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
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3 January 2012
British Government Launches Investigation of PIP Implants
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UK Health Secretary Andrew Lansley launched an investigation in to breast implants made by the now-bankrupt French Poly Implant Prothese (PIP) on 31 December, saying that he wants to “reassure women
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Health Canada, Facing Budget Cuts, Lays off Hundreds of Employees
25 April 2012
New Canadian Regulations Would Dramatically Expand Prescribing Authority
14 May 2012
Study: 510(k) Clearance Down 12% Since 2006, Time for Approval Up 40%
17 January 2012
Regulatory Focus: Week in Review (16-20 April)
20 April 2012
Regulatory Focus: Week in Review (9-13 April)
13 April 2012
Regulatory Focus: Week in Review (26-30 March)
30 March 2012
Regulatory Focus: Week in Review (2-6 April)
6 April 2012
Consumers Union Gears Up To Go After 510(k) Program, Urges MDUFA Markup
20 January 2012
Most Viewed
France: New Agency to Soon Replace AFSSAPS
1 May 2012
Obama Signs Order Promoting International Regulatory Cooperation
1 May 2012
Choosing the Right Regulatory Career: An Inside Look
17 February 2012
FDA Releases Long-Awaited Guidances on Biosimilar Price Competition and Innovation Act
9 February 2012
FDA Provides New Guidance for Promotional Labeling and Advertising
25 January 2012
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