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

Seeking to appease angry regulators, Novartis (NVS) committed to notifying the Food and Drug Administration 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 Aug. 2 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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