August 6, 2016
(STAT News) – The European Medicines Agency on Friday recommended suspending the sale of dozens of generic medicines — many of which are sold by Novartis and Teva Pharmaceuticals — over concerns about “flawed” studies that were conducted by an Indian clinical research organization. The move comes three months after the US Food and Drug Administration alerted an untold number of drug makers of problems at the Semler Research Center, which is located in Bangalore. An inspection last fall found “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.”
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