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CDER reorganization

This article was originally published in The Tan Sheet

Executive Summary

Office of Postmarketing Drug Risk Assessment and Office of Biostatistics would be transferred out of Office of Review Management and report directly to CDER Deputy Director Steven Galson, MD, under proposal floated by CDER Director Janet Woodcock, MD, in May 15 memo to staff. ORM would still report to Woodcock and contain ODEs I-V, but would be renamed Office of New Drugs to "more accurately and simply reflect its primary function." ORM has grown from overseeing two drug evaluation offices in 1994 to its current five drug offices, OPDRA and OB

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