The U.S. Food and Drug Administration said on Tuesday that some data from early ...
FILE PHOTO: The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring, Maryland, November 4, 2009. REUTERS/Jason Reed/File Photo
The FDA said it is carefully assessing the situation. It said the manipulation involves the accuracy of certain data from product testing performed in animals, which was used by the manufacturer to support development of its production process. Novartis’ Avexis unit informed the FDA of the data manipulation on June 28, the regulator said. Novartis acquired the therapy’s maker last year.
The manipulated data does not change the FDA’s positive assessment of information from human clinical trials, it said. The agency said it will continue to evaluate the integrity of the product testing data used in the development of Zolgensma’s manufacturing process.
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