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Breakthrough, Fast-Track Pathways Match Their Hype Of Reduced Development Times - JAMA

 
• By Michael Cipriano

Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.

Female athletes running towards finish line on track field

The US FDA's breakthrough therapy and fast-track expedited pathways appear to be living up to their hype. A research letter published in the Journal of the American Medical Association (JAMA) found that development times for drugs that land either of the designations are shorter than those for drugs that do not receive them.

According to the study, authored by Harvard Medical School associate professor Aaron Kesselheim, new drugs and biologics approved between 2012...

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