Reeling from scandal, Novartis vows to voluntarily release info on manipulated data in the future

Stat News

9 September 2019 - Seeking to appease angry regulators, Novartis committed to notifying the FDA within five business days of learning of any “credible allegation” in which manipulated data may affect a pending marketing application before the agency or regulators in other countries.

The company publicly disclosed the vow at an investor meeting on Monday, although the commitment was made to the FDA last month as part of a formal response to an 2 August inspection report of a facility. 

The report noted that Novartis apparently first became aware of manipulated data concerning a gene therapy last March, but waited to inform the agency until after the treatment was approved in May.

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Michael Wonder

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Michael Wonder

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Outcome , US , Regulation , Gene therapy , Data