FDA Resources

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August 16, 2019 – Amid a fresh scandal, this time over data manipulation for the world’s most expensive med, top Novartis execs laid out a detailed account Wednesday and defended the company’s decision not to inform the FDA until after its own internal probe wrapped up.

In the end, CEO Vas Narasimhan said the company did the “best we could.”
After FDA announced Tuesday that Novartis had turned over details on data manipulation at its gene therapy outfit AveXis—which won approval in May for its rare disease med Zolgensma—the Swiss drugmaker rounded up a group of execs for a conference call Wednesday to offer its version of events.