The CEO of Novartis, Vasant Narasimhan, had told an investor conference for making new commitments to the U.S. FDA on reporting regular data integrity issues, considering its fallout from the latest data manipulation on gene therapy Zolgensma.
Novartis had claimed to be more proactive in reporting data integrity issues to the U.S. FDA. The CEO said, "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.”