FDA tightens standards for new diabetes drugs

By: Associated Press
By: Associated Press

December 17, 2008

WASHINGTON (AP) -- The Food and Drug Administration says new
drugs for treating diabetes must be more closely scrutinized for
heart risks.

Drug companies will have to test new diabetes drugs on greater
numbers of high-risk patients, and run the studies longer -- at
least a year instead of several months.

A cardiologist who warned about the heart attack risks from the
diabetes drug Avandia thinks with its new policy, "the FDA got
this one right."

But industry analysts say the new rules will make it more costly
and time-consuming for companies to develop drugs that lower blood
sugars. Well over 100 such medications are in some stage of
development.

(Copyright 2008 by The Associated Press. All Rights Reserved.)


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