CBER Director Peter Marks (Jim Lo Scalzo/Pool via AP Images)

CBER's Pe­ter Marks shares pan­dem­ic lessons as FDA con­tin­ues 'go­ing through the back­log'

The FDA will like­ly take the rest of this cal­en­dar year to catch up on a back­log of work that was set aside dur­ing the Covid-19 pan­dem­ic, CBER di­rec­tor Pe­ter Marks said Mon­day at the 2023 BIO con­fer­ence.

Marks not­ed there’s “an aw­ful lot to catch up on” as the agency emerges from the pan­dem­ic, point­ing out the push for RSV vac­cines as well as vac­cines for trop­i­cal ill­ness­es. The agency al­so racked up a back­log of in­spec­tions amid the pan­dem­ic that grew in­to the thou­sands, though CDER di­rec­tor Pa­trizia Cavaz­zoni said back in June that reg­u­la­tors had caught up on do­mes­tic pre-ap­proval in­spec­tions, ac­cord­ing to a re­port from RAPS.

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