Question- What is the intent of the FDA’s “breakthrough therapy designation”?
Answer- The cited article notes “In 2012 Congress created the “break-through therapy” designation to expedite Food and Drug Administration testing and approval of medications that were intended to treat serious or life-threatening conditions and that preliminary evidence suggested may provide a substantial improvement over existing treatments with regard to one or more clinically significant end points.” (Darrow JJ et al. The FDA “breakthrough-drug designation-four years of experience. 2018 NEJM 378(15): 1444-1453)
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