Posted by Michael Wonder on 17 Jul 2018
Are 'breakthrough' drugs as safe as other FDA approved medicines?
17 July 2018 - New research questions the quality of drugs given the "breakthrough therapy" designation by the US FDA.
In late 2012, the FDA created this designation to speed the process for reviewing not-yet-approved experimental medicines intended to treat serious or life-threatening conditions.
Commonly, the clinical trials supporting breakthrough drugs lack some of the scientifically rigorous features found in the research backing drugs that have not been granted that designation, a new study published in Tuesday in JAMA found.
