FDA’s CDER es­tab­lish­es new cen­ter of ex­cel­lence fo­cused on quan­ti­ta­tive med­i­cine

The FDA is strength­en­ing its fo­cus on us­ing math­e­mat­i­cal sim­u­la­tion and mod­el­ing to guide drug de­vel­op­ment with a new cen­ter of ex­cel­lence housed in the Cen­ter for Drug Eval­u­a­tion and Re­search, the agency an­nounced Mon­day.

The Quan­ti­ta­tive Med­i­cine Cen­ter of Ex­cel­lence will be tasked with fa­cil­i­tat­ing the ap­pli­ca­tions of quan­ti­ta­tive med­i­cine (QM) as it evolves. QM has been used across sev­er­al dif­fer­ent ar­eas, in­clud­ing bio­mark­er-end­point de­vel­op­ment, clin­i­cal tri­al sim­u­la­tions, as well as ma­chine learn­ing and ar­ti­fi­cial in­tel­li­gence. It’s hap­pen­ing as the FDA fo­cus­es more on us­ing math­e­mat­i­cal sim­u­la­tions in drug de­vel­op­ment. The agency in 2022 wrapped up a suc­cess­ful pi­lot pro­gram that gave spon­sors ad­di­tion­al ac­cess to the FDA to aid in mod­el-in­formed drug de­vel­op­ment.

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