Fast Track Pathway May Be ‘Poor Man’s Breakthrough’ But It Works
Most requests for the FDA’s less-heralded expedited review designation are based on Phase II or earlier data, and have a greater chance of success than requests for breakthrough designation.
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Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.