This is the FDA’s year to shine, but can biopharma keep up as regulators continue to rev up chart-topping numbers?
The year isn’t quite over yet, but it’s clear that the FDA is giving itself high marks for productivity and overall performance for 2018. And they probably won’t get much pushback from the industry on that score, where the approval rating for agency commissioner Scott Gottlieb continues to run sky high after his first full year in that position.
A year-to-date FDA self-assessment from Khushboo Sharma, the acting chief of the Office of New Drugs, highlights the new record for drug approvals in 2018, with 55 NMEs green-lighted — with a chart-topping 42 priority reviews.
This is no fluke. Sharma provided a breakdown on the number of INDs filed with the agency — which continues to be the premier place where drug developers go to seek their first OK.
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