Questions pile up for Novartis as senators call on FDA to take action
Why wait three months to tell the FDA about manipulated data? Why wait two months between documenting an initial issue and opening a nonconformance report (NCR)? And how harshly will the FDA act?
These questions and more are piling up for Novartis, following last week’s announcement that the FDA is investigating the company for manipulating data linked to its $2.1 million gene therapy Zolgensma (onasemnogene abeparvovec-xioi). In Europe, regulators have already pulled the gene therapy’s accelerated assessment for a longer, standard assessment.
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