Novartis violated FDA’s sacred principle: in God we trust, all others must bring data

Stat News

14 August 2019 - A common saying at the Food and Drug Administration is: “In God we trust, all others must bring data.” 

The independent evaluation of science is an essential element of the FDA’s dual role of protecting the public health and promoting innovation to bring new therapies into practice. In fact, with certain exceptions, the FDA is the only regulatory agency for drugs and devices that independently evaluates both the science and the source data from relevant studies. 

In many ways, the FDA serves the world as an arbiter of quality in the global development of medicines.

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Michael Wonder

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Michael Wonder

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US , Regulation , Gene therapy