FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Of­fice of Tis­sue and Ad­vanced Ther­a­pies (OTAT) trans­forms in­to the Of­fice of Ther­a­peu­tic Prod­ucts (OTP), with new user fee funds and “su­per of­fice” sta­tus, the de­part­ment fo­cused on cell and gene ther­a­pies al­so opened its doors to a town hall Thurs­day of­fer­ing clar­i­fi­ca­tion on guid­ance and reg­u­la­tions for man­u­fac­tur­ers.

Some of the ma­jor con­cerns from man­u­fac­tur­ers were the CMC con­sid­er­a­tions be­tween first-in-hu­man stud­ies and late-phase stud­ies sup­port­ing a mar­ket­ing ap­proval.

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