An independent panel of experts has called for the diabetes drug Avandia to be pulled from the shelves in the UK according to the Medicines and Healthcare products Regulatory Agency (MHRA). However, MHRA is not taking action at this time stating that “would cause confustion” and that they are waiting for a decision by the European Medicines Agency. A furor has broke out among experts on why the drug was approved in the first place. The Guardian newspaper reports the following:
“A BBC Panorama documentary broadcast tonight and a BMJ article published today question whether there has been a failure of the UK’s regulatory system. The BMJ article asks whether there was sufficient clinical evidence in the first place for the product to be licensed by the European Medicines Agency (EMA) in 2000.”
The EMA is due with an opinion later this month and GSK, the maker of Avandia, stated: “patient safety is our priority”.
Avandia has caused quite a furor in the United States as well. The drug’s future remains unclear. Read GxP Perspectives Coverage of
Avandia Advisory Committee Meetings
Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.
The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.
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Read the updated article on the Form FDA 1572 in:
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