CBER di­rec­tor Pe­ter Marks says FDA is grow­ing to keep up with cell and gene ther­a­pies

SOMERVILLE, MA — CBER di­rec­tor Pe­ter Marks spelled out FDA’s plans to keep up with the fast-grow­ing cell and gene ther­a­py space on Tues­day, while al­so ad­vo­cat­ing for the use of ac­cel­er­at­ed ap­provals.

“This area has grown so much over the past decade that we have not grown with it,” Marks said at Charles Riv­er’s Cell & Gene Sum­mit Tour just out­side of Boston. That’s about to change, he added, as the FDA of­fi­cial­ly tran­si­tioned on Mon­day from its Of­fice of Tis­sues and Ad­vanced Ther­a­pies (OTAT) to the Of­fice of Ther­a­peu­tic Prod­ucts (OTP).

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