Pharmacovigilance Feeds EMA’s Transparency Drive
The scandal surrounding the withdrawal of Servier’s diabetes drug Mediator (benfluorex) continues to rock the French medical establishment, but it also has drawn attention to the issue of regulators' transparency more broadly – including at the European Medicines Agency.
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French Drug Industry Group Kicked Off Key Gov't Committee
France will eliminate industry seat on the nation's HTA transparency panel, in apparent continuing Mediator fall-out.
ICH Reforms Will "Professionalize" Harmonization, PhRMA's Rep Says
Shift in balance of power to regulators is "appropriate" and it's important that the public has trust in ICH, PhRMA Associate VP for Scientific and Regulatory Affairs Patrick Brady says; FDA proposes to contribute $500,000 per year to revised group.
EMA Leadership Goes To Pott After Rasi Retroactively Unhired
Andreas Pott, who helped steer agency through Mediator scandal, becomes acting director again as irregularities in 2011’s recruitment process force departure of Guido Rasi – who himself might still get top job again once hiring process reboots.