FDA reorganizes Office of Generic Drugs

Creates new divisions, formalizes deputy director position

SILVER SPRING, Md. — The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

The new organizational scheme will add a new division to the bioequivalence program called Division of Bioequivalence II and a new chemistry division, Division of Chemistry IV.

The microbiology and clinical review staffs also have been converted into the Division of Microbiology and the Division of Clinical Review. The Division of Labeling and Program Support remains the same. Meanwhile, the reorganization has formalized the position of deputy director for science and chemistry, currently held by Lawrence Yu.

"The reorganization is a major step in [the Center for Drug Evaluation and Research's] efforts to advance the public health as the use of generic drugs continues to increase," read the memo, written by Office of Pharmaceutical Science director Helen Winkle.

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