What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows.
The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence in new drug claims.
As the researchers on the new study describe it, the FDA Safety and Innovation Act, passed in 2012, allows the FDA to give breakthrough designation to any drug treating a serious or life-threatening condition that “may demonstrate a substantial improvement over existing therapies” for one clinical endpoint, or outcome, in preliminary evidence.
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