A go-go FDA is poised to break the all-time record on new drug approvals. Is this the new standard for biopharma success?
Last year at this time, the FDA was beginning to reach into Q1 of 2018 to hurry up a slate of new drug approvals that pushed the agency to a new record high, both a current-generation agency best as well as an overall spike that broke into virgin territory for the first time in 20 years — provided you added a group of major new biologics to the new therapeutics list.
This year, it looks like the FDA will have the luxury of breaking through the finish line at the end of December after putting the old record — set in 1996 — to shame just by sticking with the PDUFA dates on hand. And they’ve proven beyond doubt that they’re not likely to do that.
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