Ex­clu­sive: Turnover tsuna­mi at FDA's phar­ma in­spec­tions of­fice puts the back­log in sharp fo­cus

Hir­ing has al­ways been an is­sue for the FDA, par­tic­u­lar­ly for those with ex­per­tise in phar­ma and biotech as they can quick­ly move over to the in­dus­try and earn dou­ble or triple what they make at the fed­er­al agency.

But a re­cent staff crunch and a surge in the turnover for qual­i­ty op­er­a­tions in­spec­tors at the FDA this year is be­com­ing par­tic­u­lar­ly no­tice­able for com­pa­nies that re­ly on agency in­spec­tions to win ap­provals, even if the re­cent case of No­var­tis and BeiGene miss­ing their PDU­FA date due to an in­spec­tion was more of an is­sue with Chi­nese trav­el re­stric­tions.

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