An FDA report reveals the agency believed Novartis data problems were resolved months ago

Stat News

27 August 2019 - Shortly before serious data problems surfaced in mid-March at a troubled Novartis unit, a Food and Drug Administration report noted the company had recently conducted an “extensive investigation” after finding errors and discrepancies in a preclinical test. 

The agency apparently believed the difficulties had been rectified.

In a February 2019 report, FDA personnel noted that AveXis — the Novartis unit at the centre of a scandal over manipulating data for the gene therapy — uncovered problems with a so-called mouse assay.

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Michael Wonder

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Michael Wonder

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US , Regulation , Gene therapy