FDA set to open com­ments on AI use in phar­ma man­u­fac­tur­ing

The FDA wants to know what peo­ple think about the use of AI in the phar­ma man­u­fac­tur­ing space.

Ac­cord­ing to a pub­lic in­spec­tion doc­u­ment, the FDA plans to pub­lish a re­quest for in­for­ma­tion no­tice on Wednes­day, aim­ing to gath­er pub­lic com­ments on “emerg­ing and ad­vanced” man­u­fac­tur­ing tech, specif­i­cal­ly in ar­ti­fi­cial in­tel­li­gence’s use in phar­ma man­u­fac­tur­ing.

The pa­per will lay out “ar­eas for con­sid­er­a­tions and pol­i­cy de­vel­op­ment” from the Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) sur­round­ing AI in phar­ma­ceu­ti­cal man­u­fac­tur­ing. The pa­per is meant to en­cour­age and gath­er feed­back from the pub­lic, peo­ple in the in­dus­try, as well as CDER and the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER).

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