Breakthrough Therapy Designations: Phase II Data Is Sweet Spot For US FDA Award
Pink Sheet analysis finds that evidence from early-stage trials supports most BTD requests, but about three in 10 designations are granted on the basis of pivotal-stage data.
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A dozen applications for new drugs and significant new indications are on the US FDA’s calendar of goal dates, including breakthrough-designated applications from Bristol-Myers Squibb and Boehringer Ingelheim.
The agency needs more experience making the decisions before it lays out the evidence threshold for a breakthrough designation, CDER Director Janet Woodcock says.
Health-system pharmacist organization assesses the evidence behind off-label use of existing drugs for COVID-19, along with top investigational prospects like Gilead’s remdesivir.