Tran­si­tion­al lead­ers take charge as FDA be­gins PhI­II of OND re­or­ga­ni­za­tion

The FDA on Tues­day of­fi­cial­ly be­gan Phase III of its Of­fice of New Drugs (OND) re­or­ga­ni­za­tion af­ter a short de­lay, and sev­er­al lead­ers of the new of­fices took charge in an act­ing ca­pac­i­ty, ac­cord­ing to an email from OND Di­rec­tor Pe­ter Stein.

Phase III of the re­or­ga­ni­za­tion was ini­tial­ly ex­pect­ed to be­gin on 13 Jan­u­ary but was pushed back due to mi­nor de­lays last week.

Dur­ing Phase III, OND will be stand­ing up two new of­fices, the Of­fice of Non­pre­scrip­tion Drugs (ON­PD) and the Of­fice of Spe­cial­ty Med­i­cine (OSM), as well as the Di­vi­sion of Reg­u­la­to­ry Op­er­a­tions for Spe­cial­ty Med­i­cine un­der the Of­fice of Reg­u­la­to­ry Op­er­a­tions (ORO).

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