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US FDA's Rush Following Novartis' Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation

 
• By Brenda Sandburg

Early release of inspection findings is unusual, signaling likelihood that Novartis will face tough scrutiny of its actions, and perhaps stiff fines because of the fraud.

One question hanging over Novartis AG's decision to delay telling the US Food and Drug Administration that its scientists had manipulated Zolgensma data is whether there will be legal fallout. While the answer is uncertain, the company is likely to face closer government scrutiny of its actions.

Other companies have been embroiled in Department of Justice investigations for data fraud, most notably Ranbaxy Laboratories Ltd., which in 2013 paid $500m to resolve allegations it submitted fraudulent...

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