FDA’s Office Of Regulatory Affairs To Be Headed By Agency Veteran
This article was originally published in The Pink Sheet Daily
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.
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While Mylan wants Autor to help push quality improvement efforts around the world, her departure from FDA may affect implementation of similar plans at the agency.
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.
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.