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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