FDA's OTAT morphs in­to the Of­fice of Ther­a­peu­tic Prod­ucts as new funds await

Ready for a makeover with new PDU­FA VII funds on deck, the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search said Tues­day that they will reti­tle the Of­fice of Tis­sues and Ad­vanced Ther­a­pies to the Of­fice of Ther­a­peu­tic Prod­ucts (OTP) and el­e­vate it to “Su­per Of­fice” sta­tus, which will in­crease its re­view ca­pa­bil­i­ties, and en­hance its ex­per­tise on new cell and gene ther­a­pies.

“Ad­di­tion­al su­per­vi­so­ry po­si­tions will not on­ly help to ad­dress this in­creased work­load but will al­so pro­vide ad­vance­ment op­por­tu­ni­ties to fa­cil­i­tate re­cruit­ment and re­ten­tion of high­ly qual­i­fied staff,” the agency said Tues­day in a Fed­er­al Reg­is­ter no­tice.

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