WebJan 28, 2024 · Introduction. Drug companies can request a Breakthrough Therapy (BT) designation from the US Food and Drug Administration (FDA) for drugs intended to treat a serious medical condition if preliminary clinical evidence indicates substantial improvement on one or more clinically significant endpoints compared with available therapies. 1, 2 In … WebMar 15, 2024 · Ellen Sigal, the founder of Friends of Cancer Research, discusses the origins and future of the FDA’s breakthrough therapy designation as well as the changing …
Reflections on 10 years of the FDA’s breakthrough …
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Breakthrough Therapy Designation Requests FDA
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