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FDA Office of Regulatory Affairs Make-Over Blends Domestic, International Work

Executive Summary

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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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.

In Brief

More FDASIA reorganizations at FDA; Key QbD elements expected in ANDA supplements.

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