The FDA on Data Accuracy

18 September 2019

By Dr Nicola Davies

With the news of data manipulation in Novartis’ preclinical trials of Zolgensma (onasemnogene abeparvovec-xioi), questions have arisen around the FDA’s opinions on data accuracy and integrity. Zolgensma, a gene therapy for spinal muscular atrophy (SMA) in children, is currently the most expensive drug on the market, with a single dose costing up to $2.1million.1,2 In her exclusive column for the Pharma Letter, Dr Nicola Davies explores the measures put in place to tackle data accuracy after the fallout of the Novartis scandal.

The Novartis saga

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