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Data Manipulation Not Common, But Happens "More Than I Would Have Expected," US FDA's Sharpless Says

 
• By Michael Cipriano

As fallout from the Novartis Zolgensma data manipulation incident continues, US FDA acting commissioner Norman Sharpless notes that "at some level we have to trust the sponsors."

FDA acting Commissioner Ned Sharpless speaking at FDLI 2019
Norman Sharpless broadly addressed the frequency of data manipulation at the US FDA.

Data manipulation is not something the US Food and Drug Administration encounters often, but acting commissioner Norman Sharpless says it happens more often than he thought before he got to the agency.

"Now I don't want to imply that this is rampant ... and I also don't want to imply that we think this is something on the upswing," Sharpless said on 5 September at Research!America’s National Health Research Forum. "In fact, we have no data to suggest that. Such cases may even be becoming more rare

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