Category Archives: Safety

Compounded Drug Crisis Spotlights Regulatory Confusion

By Guest Blogger | Published: October 9, 2012
Compounded drug crisis spotlights regulatory confusion The call for stiffer FDA regulation of compounded drugs has been reignited by a national fungal meningitis outbreak. Last week, the Centers for Disease Control and Prevention (CDC) reported 7 deaths linked to contaminated vials of steroid injectables from a Massachusetts compounding operation. 91 people have been taken ill, with [...]
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Monsanto's Rat Tumor Scare: A Wake-Up Call for the Pharma Industry?

By Guest Blogger | Published: September 25, 2012
ARE Monsanto’s RAT-TUMOUR SCARES A WAKE-UP CALL TO THE PHARMA INDUSTRY? By Reflector, Brussels correspondent. The furore that burst across Brussels in late September over reported findings of tumors in rats fed with genetically modified maize may seem only tangentially related to the concerns of European pharmaceutical executives — but the significance of the debate it has [...]
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Sanofi's Aubagio to Square Off Against MS Injectables

By Ben Comer | Published: September 13, 2012
The most obvious competitors for Sanofi’s Aubagio, the second oral multiple sclerosis (MS) drug to receive FDA approval, would appear to be Novartis’ Gilenya, and Biogen Idec’s hotly anticipated BG-12, which has a PDUFA date scheduled for December 28. Both Gilenya and BG-12 are administered orally as opposed to injected, but execs at Genzyme – [...]
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Working Out the Kinks in Health IT

By Ben Comer | Published: September 12, 2012
Industry executives and government officials convened in Washington DC yesterday to examine the present state of health information technology (HIT), and to identify the bugs, challenges and hiccups that continue to plague EHR platforms, and the policies that regulate them.
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FDA, AdvaMed Seeking Clarity on Med Device Pre-Market Approvals

By Guest Blogger | Published: September 5, 2012
by Elizabeth Hollis The FDA and the Advanced Medical Technology Association (AdvaMed) gave cardiovascular device manufacturers plenty to think about over the holiday weekend with information presented at an Aug. 28 workshop. The two bodies came together to explain requirements for 30-day notices and annual change reports for Pre-Market Approvals (PMAs), an important gateway to [...]
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