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Transitional Leaders Take Charge as FDA Begins Phase III of OND Reorganization

Posted 21 January 2020 | By Michael Mezher 

Transitional Leaders Take Charge as FDA Begins Phase III of OND Reorganization

The US Food and Drug Administration (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).
 
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.
 
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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