New drug OKs fell off a cliff in 2016 and the FDA wants you to know why

The FDA’s John Jenk­ins has one more an­nu­al re­view on new drug ap­provals be­fore he re­tires as di­rec­tor of the Of­fice of New Drugs. And it’s not a pret­ty pic­ture.

Af­ter track­ing surg­ing new drug ap­provals for much of the past 5 years, which helped al­le­vi­ate con­cerns about the in­dus­try’s over­all R&D pro­duc­tiv­i­ty rate, the agency post­ed on­ly 19 new BLAs and NDAs in 2016 — a low the agency hasn’t seen since the bad old days of 2007.

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