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# FDA Reorganization Involves One-Third of CDER Offices
- URL: https://www.fdaweb.com/fda-reorganization-involves-one-third-of-cder-offices/
- Published: 2018-07-19T12:00:00.000Z
- Updated: 2026-09-15T00:20:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141913

CDER director **Janet Woodcock** says that an FDA reorganization plan submitted to HHS for approval before going to Congress for concurrence will affect nearly one-third of CDER offices. “The changes within CDER offices will enable us to respond to new priorities more efficiently with a stronger organizational framework and better resources,” she writes in a [memo](http://www.fdaweb.com/download.php?file=CDER%5FReorg%5F7-19-2018.docx) to staff. “As part of this reorganization, CDER will undergo structural changes within four offices in the Center: Office of New Drugs, Office of Compliance, Office of Executive Programs, and Office of Communications.” She spells out these highlights: 

- **Office of New Drugs** – establishing a new Office of Therapeutic Biologics and Biosimilars to give biosimilar and interchangeable product reviews a stronger infrastructure with resources to streamline and advance policy development.
- **Office of Compliance** – creating a more robust structure that will advance its compounding program and improve the ability to shield patients from poor quality, unsafe, and ineffective drugs through compliance and enforcement actions. The Office of Unapproved Drugs and Labeling Compliance will house a Division of Compounded Drugs. The Office of Manufacturing Quality will establish a third drug quality division with two branches for global compliance.
- **Office of Executive Programs** – promoting enhanced leadership, communication, and oversight of expanding core functions, including Center-wide special projects focused on user fee program support and implementation, coordination of executive and legislative activities, and advisory committee meeting management and planning.
- **Office of Communications** – allowing for more systematic, proactive outreach and education of CDER programs and activities, including expanding efforts to inform FDA stakeholders and the public through more communication channels, broadening the social media presence, and employing innovative tools.

“I’m pleased to reach another milestone in our continued journey to ensure that CDER is best positioned to meet the needs of those we serve,” Woodcock says. “These changes … reflect how critical it is for us to establish an organizational structure that strengthens our foundation and streamlines functions to maximize efficiency.”