IT IS OFFICIAL: MORE THAN 700 GENERICS LINKED TO INDIAN DRUGMAKER SUSPENDED IN EU:
The Commission formally adopted the EMA panel recommendation to suspend use of about 700 generic drugs tested by the suspect Indian clinical trial company GVK Biosciences, Le Monde reports. http://bit.ly/1LMAYyc
Recall that the EMA in January had opened an investigation into GVK and concluded that data on electrocardiograms had been manipulated during some studies over five years, working off a tip from the French drug safety agency.
A Le Monde editorial calls the ban a “wake-up call” (more literally, “a call to order”) and highlights just how dangerously opaque clinical trialing for Indian and Chinese generic medicines can be — and just how vulnerable Europe is as a result. http://bit.ly/1D1HZrT
Find the EMA notice from May here: http://bit.ly/1KtvGXS
The Commission formally adopted the EMA panel recommendation to suspend use of about 700 generic drugs tested by the suspect Indian clinical trial company GVK Biosciences, Le Monde reports. http://bit.ly/1LMAYyc
Recall that the EMA in January had opened an investigation into GVK and concluded that data on electrocardiograms had been manipulated during some studies over five years, working off a tip from the French drug safety agency.
A Le Monde editorial calls the ban a “wake-up call” (more literally, “a call to order”) and highlights just how dangerously opaque clinical trialing for Indian and Chinese generic medicines can be — and just how vulnerable Europe is as a result. http://bit.ly/1D1HZrT
Find the EMA notice from May here: http://bit.ly/1KtvGXS
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