FDA plots chal­lenges in im­ple­ment­ing new laws tar­get­ing phar­ma sup­ply chain

BOSTON — Sev­er­al new laws – en­com­pass­ing the next five years of bio­phar­ma in­dus­try user fees and some add-ons to fed­er­al gov­ern­ment fund­ing – set up some ma­jor changes for the FDA when it comes to bio­phar­ma qual­i­ty.

As part of what’s known as the Food and Drug Om­nibus Re­form Act or FDO­RA, Ash­ley Boam, di­rec­tor of the of­fice of pol­i­cy in FDA’s Of­fice of Phar­ma­ceu­ti­cal Qual­i­ty, ex­plained to at­ten­dees at DIA’s 2023 an­nu­al con­fer­ence on Tues­day how there are new risk fac­tors that can be used to pri­or­i­tize cer­tain in­spec­tions of phar­ma man­u­fac­tur­ing sites, but it re­mains to be seen how that will work in prac­tice.

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