Pharmaceutical & Life Sciences News

Does Faster Mean Better for Cancer Drugs? This Study Says No

May 2, 2018, 8:30 PM

The FDA may be creating expectations among seriously ill patients that are unlikely to be fulfilled by designating new cancer drugs as breakthrough therapies, a Harvard Medical School faculty member told Bloomberg Law.

Jonathan J. Darrow was taking aim at an almost six-year-old program that allows drug companies to get their medicines reviewed by the Food and Drug Administration more quickly—if a drug treats a serious medical condition, and if it can demonstrate substantial improvement over existing therapies. The FDA’s breakthrough therapy program is shaving about two years off the time it takes for these drugs to get on the...

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