Problems with China Trial Data of BMS/Pfizer Blood Thinner Caused Delay in Approval
publication date: Jul 9, 2013
China promotes itself as a great place to conduct global clinical trials. It features low costs and the world’s largest population, most of whom are treatment naïve. But according to documents recently released by the US FDA, the China arm of a global trial caused a nine-month delay in the approval process of Eliquis, a major new product. The reason? There were errors in the data, the wrong drugs may have been administered and adverse events were covered up. More details....
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