(RTTNews) - Novartis (NVS) has 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.
"We are making a voluntary commitment to notify the FDA within five business days of receipt by our quality (control) organization of any credible allegation related to data integrity impacting any pending application in the Novartis Group," Chief Executive Officer Vas Narasimhan said at an investor event. The company will take a similar approach in other jurisdictions.
The commitment was made to the FDA last month as part of a formal response to an August 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.