FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Woodcock Outlines Reorganization of CDER Offices

July 23, 2018
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CDER Director Janet Woodcock released details of a major overhaul of four CDER offices Thursday aimed at improving the center’s ability to respond to new priorities.

The proposed restructuring will reorganize CDER’s Office of New Drugs, the Office of Compliance, the Office of Executive Programs and the Office of Communications.

The OND will gain an Office of Therapeutic Biologics and Biosimilars to bolster reviews of biosimilars and interchangeable products as well as biologics.

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