AI and ma­chine learn­ing: FDA spells out specifics from drug dis­cov­ery to man­u­fac­tur­ing

From drug tar­get iden­ti­fi­ca­tion and ear­ly dis­cov­ery work to post­mar­ket sur­veil­lance and ad­vanced man­u­fac­tur­ing, the FDA on Wednes­day out­lined its key rec­om­men­da­tions on how to use ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing, two new and key com­po­nents to drug de­vel­op­ment that the agency is try­ing to bet­ter un­der­stand.

The 31-page dis­cus­sion pa­per and web­site note that the FDA has seen a sig­nif­i­cant in­crease in the num­ber of drug and bi­o­log­ic ap­pli­ca­tion sub­mis­sions us­ing AI/ML com­po­nents over the past few years, with more than 100 sub­mis­sions re­port­ed in 2021.

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