Looking to slow the fallout from Novartis’ data manipulation fiasco with its billion-dollar gene therapy Zolgensma, CEO Vasant Narasimhan told an investor conference this week that the company will be more proactive in reporting data integrity issues to the US FDA. “We are voluntarily and proactively taking a pledge with the FDA to ensure that we will inform them within five business days of any credible allegation related to data integrity,” Narasimhan said. He also said Novartis has responded to FDA’s Form 483 and is making documents available as requested, while reiterating that the data manipulation uncovered at the San Diego site “does not impact the safety, efficacy or quality of Zolgensma.” Learn More