Got­tlieb, Marks de­tail plans to ad­vance de­vel­op­ment of cell and gene ther­a­pies

FDA Com­mis­sion­er Scott Got­tlieb and Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER) Di­rec­tor Pe­ter Marks on Tues­day de­tailed plans for the agency to keep pace with an ex­pect­ed in­flux of ap­pli­ca­tions for cell and gene ther­a­pies over the com­ing years.

“The FDA is wit­ness­ing a surge of cell and gene ther­a­py prod­ucts en­ter­ing ear­ly de­vel­op­ment, ev­i­denced by a large up­swing in the num­ber of in­ves­ti­ga­tion­al new drug (IND) ap­pli­ca­tions,” Got­tlieb and Marks say.

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