Over­worked and ready for ex­pan­sion: FDA's cell and gene ther­a­py of­fice preps to add about 100 new po­si­tions

Housed with­in the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, the once-tiny Of­fice of Tis­sues and Ad­vanced Ther­a­pies, which reg­u­lates all cell and gene ther­a­py prod­ucts, has been pum­meled with a work­load that now in­cludes more than 3,000 ac­tive INDs.

That pun­ish­ing work­load has trans­lat­ed in­to OTAT staff de­fec­tions, the of­fice di­rec­tor, Wil­son Bryan, told par­tic­i­pants Mon­day at the Amer­i­can So­ci­ety of Gene and Cell Ther­a­py’s pol­i­cy sum­mit.

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