In August, Novartis said it knew about discrepancies in data it had submitted to regulators as it sought approval of Zolgensma, but delayed notifying authorities until it completed an internal investigation.
ZURICH: Novartis Chief Executive Vas Narasimhan promised to inform U.S. regulators quickly if credible questions emerge internally over data integrity, he told investors on Monday, following data manipulation allegations involving the Swiss drugmaker’s $2.1 million gene therapy Zolgensma.
“Although we are confident that the actions we are taking will prevent data integrity issues from occurring in the future, going forward we are making a voluntary commitment to notify the FDA within five business days of receipt by our quality organization of any credible allegation related to data integrity impacting any pending application in the Novartis Group,” Narasimhan said as part of an investor event.
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In August, Novartis said it knew about discrepancies in data it had submitted to regulators as it sought approval of Zolgensma, but delayed notifying authorities until it completed an internal investigation.
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