FDA Office of Regulatory Affairs Make-Over Blends Domestic, International Work
The reorganized ORA has eight new offices to better handle new legislative authorities and globalization of its regulated products; FDA expects to increase partnerships with other government officials and foreign entities.
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Melinda Plaisier, who has been acting Associate Commissioner for Regulatory Affairs for the past year, was named to the position; appointment comes following several leadership changes in ORA.
Howard Sklamberg, deputy associate commissioner in FDA’s Office of Regulatory Affairs, will take over as director of the Center for Drug Evaluation and Research’s Compliance Office in January; acting compliance director Ilisa Bernstein will resume her role as deputy director.
More FDASIA reorganizations at FDA; Key QbD elements expected in ANDA supplements.