Tran­si­tion­al lead­ers take charge as FDA be­gins PhI­II of OND re­or­ga­ni­za­tion

Pe­ter Stein FDA

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).

The FDA on Tues­day an­nounced that ORO, which was es­tab­lished in Phase I of the mod­ern­iza­tion, will be led by Of­fice Di­rec­tor Jen­nifer Merci­er and Deputy Di­rec­tor Jacque­line Ware. OSM, formed from di­vi­sions in the Of­fice of An­timi­cro­bial Prod­ucts and the Of­fice of Drug Eval­u­a­tion IV, will be over­seen by Of­fice Di­rec­tor Charles Gan­ley and act­ing Deputy Di­rec­tor Alex Gorovets.

“Im­ple­men­ta­tion will oc­cur over the next sev­er­al weeks, as ad­di­tion­al lead­er­ship is se­lect­ed for the Of­fices of Non­pre­scrip­tion Drugs and Spe­cial­ty Med­i­cine,” Stein said.

The FDA up­dat­ed its web­page de­tail­ing which ap­pli­ca­tions may be af­fect­ed by the re­or­ga­ni­za­tion, not­ing that with the start of Phase III ap­pli­ca­tions orig­i­nal­ly as­signed to the Di­vi­sion of Non­pre­scrip­tion Drugs of Of­fice of Drug Eval­u­a­tion (ODE) IV, the Di­vi­sion of Trans­plant and Oph­thal­mol­o­gy Prod­ucts un­der the Of­fice of An­timi­cro­bial Prod­ucts and the Di­vi­sion of Med­ical Imag­ing Prod­ucts of ODE IV may be im­pact­ed.

Phase I and Phase II of the re­or­ga­ni­za­tion means that as new of­fices are formed, some com­po­nents will op­er­ate in tran­si­tion un­til their new of­fices are formed in the fi­nal Phase IV of the re­or­ga­ni­za­tion.

For in­stance, ON­PD, formed from the Di­vi­sion of Non­pre­scrip­tion Drug Prod­ucts in the Of­fice of Drug Eval­u­a­tion IV, will be led by an act­ing of­fice di­rec­tor, Ter­ri Michele, and act­ing Deputy Di­rec­tor Karen Ma­honey. The Di­vi­sion of Non­pre­scrip­tion Drug Prod­ucts (DNDP) will be split in­to two di­vi­sions (DNPD I and DNPD II), with Michele and Ma­honey serv­ing tem­porar­i­ly as act­ing di­vi­sion di­rec­tors.

The Di­vi­sion of Oph­thal­mol­o­gy al­so cur­rent­ly has an act­ing di­vi­sion di­rec­tor, Wi­ley Cham­bers, while the Di­vi­sion of Med­ical Imag­ing Prod­ucts will be­come the Di­vi­sion of Med­ical Imag­ing and Ra­di­a­tion Med­i­cine, cur­rent­ly over­seen by act­ing Di­vi­sion Di­rec­tor Libero Marzel­la and Gorovets.


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