Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first sev­er­al months of the pan­dem­ic last spring, the FDA con­tin­ued to plow through its user fee-en­abled work on new drug and bi­o­log­ic ap­pli­ca­tions, meet­ing near­ly all of its goal dates.

But by last fall and in­to the win­ter, com­plete re­sponse let­ters and oth­er de­lays be­gan ar­riv­ing in com­pa­nies’ mail­box­es as the agency strug­gled to catch up to a grow­ing back­log of both do­mes­tic and for­eign drug man­u­fac­tur­ing in­spec­tions.

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