USA – FDA kicks off 3rd phase of OND restructuring

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…