Quicker FDA approval via breakthrough status lauded by drugmakers

07/25/2013 | Reuters

Some drugmakers whose treatments obtained breakthrough therapy status from the FDA said the new regulatory pathway could speed the country's traditional drug approval process by years. Johnson & Johnson's Dr. Jay Siegel said he expects an FDA review of the company's candidate cancer drug ibrutinib that is faster by two years. Communications under the breakthrough designation can be accomplished in minutes rather than weeks and months, said Vertex Pharmaceuticals CEO Dr. Jeffrey Leiden.

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