11th Circ. Rips FDA's 'Invisible Ink' Interpretation Of Drug Act

By Rosie Manins ( March 23, 2021, 3:10 PM EDT) -- An Eleventh Circuit judge criticized the U.S. Food and Drug Administration's interpretation of the Orphan Drug Act during oral arguments Tuesday over its approval for two companies to make the same rare-disease drug, suggesting statutory text supporting its argument must have been written in "invisible ink."...

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