On August 6, FDA announced that Novartis’s application for approval of Zolgensma contained “manipulated” data and that the company knew this while the application was pending, but did not tell the agency. Three days later a group of Senators wrote FDA a letter asking, among other things, why the agency had withdrawn a proposed regulation that would have required “sponsors of certain clinical trials to promptly report suspected data falsification to FDA.” It may be helpful to review the concerns that people raised. Details after the jump.
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