Blip or dip?

Assessing why FDA approvals are down in 2016

In a ritual held each year a couple of weeks before the winter solstice, pundits pore over FDA’s new drug approval statistics and use them to pontificate about the health of the biopharma industry and FDA’s performance. The small number of data points and the oversize effects of a handful of unanticipated failures or speed bumps make the approval statistics more suitable for numerology than rigorous diagnostic or predictive analysis.

Two years of high approvals in 2014 and 2015 weren’t the start of an inexorable upward trend, and it is impossible to know if this year’s low number -- 20 -- was a blip

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