Forced vital capacity in idiopathic pulmonary fibrosis—FDA review of pirfenidone and nintedanib

BA Karimi-Shah, BA Chowdhury - New England Journal of …, 2015 - Mass Medical Soc
BA Karimi-Shah, BA Chowdhury
New England Journal of Medicine, 2015•Mass Medical Soc
Forced Vital Capacity in Idiopathic Pulmonary Fibrosis — FDA Review of Pirfenidone and
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In 2014, the FDA approved two drugs for idiopathic pulmonary fibrosis that posed a regulatory challenge: the primary efficacy variable studied was the change in forced vital capacity, which hadn't been established as a surrogate for clinically meaningful benefit.
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