Novartis Acknowledges Huge Lapse in Clinical Trial Safety Reporting

June 11, 2014 | Following revelations in April that Novartis employees in Japan had concealed unfavorable safety reports in clinical trials, the pharmaceutical company has now disclosed that the problem was much more widespread than was previously realized. According to the results of an internal Novartis investigation, 10,000 or more safety reports may have been withheld across clinical studies of ten different drugs in the company portfolio. So far, these cases have not been linked to specific adverse events. WSJ Pharmalot


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