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FDA, EMA Lay Out Incretin Mimetic Safety Analysis In NEJM

 
• By Sue Sutter

Editorial details the breadth of data that U.S. and European regulators examined in concluding that available data are “inconsistent” with assertions that a causal association exists between incretin-based diabetes drugs and pancreatic adverse events.

U.S. and European drug regulators examined old and new studies, and conducted some original research of their own, in concluding that available data do not support a causal link between incretin mimetic diabetes drugs and pancreatic adverse events.

In a perspective piece published in the Feb. 27 issue of the New England Journal of Medicine, representatives from FDA...

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More from United States

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Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
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More from North America

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• By Cathy Kelly

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