April 12, 2016
(UPI) – Use of the word “breakthrough” in the U.S. Food and Drug Administration’s expedited approval process could mislead doctors about the new drugs’ actual benefits, researchers warn. The U.S. Congress in 2012 gave FDA the power to designate a drug as a “breakthrough therapy” if preliminary clinical evidence suggests an advantage over existing medications. But a survey of nearly 700 doctors revealed that many tended to misinterpret “breakthrough.”
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