FDA Week

Public Citizen Bashes FDA For About-Face On Previously Rejected Drug

September 07, 2017
A key consumer advocacy group points to FDA's decision to let Eli Lilly quickly resubmit a recently denied application for a rheumatoid arthritis drug as new evidence the agency is weakening approval standards under commissioner Scott Gottlieb. Lilly announced Aug. 30 that FDA will let it and Incyte Corporation resubmit a New Drug Application for Baricitinib, coming after the agency informed Lilly in April that the application lacked sufficient clinical data. Back in April, Lilly told analysts it would likely...

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