Regulatory Focus™ > News Articles > Regulatory Focus: Week in Review (8-12 October)

Regulatory Focus: Week in Review (8-12 October)

Posted 12 October 2012 | By Alexander Gaffney, RAC 

Regulatory Focus is proud to bring you another edition of Week in Review-a recap of the global regulatory news space for the preceding week. We cover news and regulatory intelligence from around the globe and bring it to you in one organized location. If you read just one thing this week, make it Regulatory Focus' Week in Review.

Week in Brief

Drug manufacturing giant GlaxoSmithKline announced it will make public all of its clinical trials data, while the US Food and Drug Administration (FDA) continues to battle a nationwide outbreak of meningitis spread through unsterile steroid injections. 

Happy 50th anniversary to the Kefauver Harris Amendments, which established FDA's authority to demand high-quality evidence and evaluate pharmaceutical products based on effectiveness.

Internationally, the European Medicines Agency (EMA) said it expects to come in slightly below projections for 2012 drug approvals and released new guidelines for developing therapies for schizophrenia and multiple sclerosis. EU-wide changes to the recently-passed pharmacovigilance legislation were also announced, calling for additional safety notifications and the closure of several potential loopholes.

Health Canada's fast-track approval pathway was meanwhile hit for having significantly higher rates of safety issues in a study published in the Archives of Internal Medicine.

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