Modernizing the New Drugs Regulatory Program: Reorganization Approved

Modernizing the New Drugs Regulatory Program: Reorganization Approved

Today the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced that the reorganization of the Office of New Drugs (OND) with corresponding changes to the Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ) has been approved. The new structure, which is expected to be fully implemented in early 2020, will strengthen OND operations and allow the office to meet the evolving needs of new drug review through greater therapeutic alignment. OPQ and OTS, which work closely with OND, are also undergoing restructuring of certain offices and divisions. The Office of Surveillance and Epidemiology will continue to work closely with OND regarding the integration of safety review work.

The guiding principles of the reorganization include therapeutic alignment, workload management, and staff development.

 Changes include:

• Grouping OND offices and divisions by therapeutic area to distribute workload and align to changes in the pharmaceutical landscape,
• Creating OND divisions with clearer and more focused areas of expertise,
• Increasing the number of clinical offices that oversee OND review divisions from six to eight,
• Increasing the number of OND clinical divisions from our current 19 divisions to 27 plus six divisions of pharmacology/toxicology and
• Establishing new OND Offices of Program, Administrative, and Regulatory Operations, an Office of New Drug Policy, and an Office of Drug Evaluation Sciences, and
• Establishing a new OPQ Office of Administrative Operations, renaming two existing OPQ offices, and creating seven new divisions across OPQ.

Through the reorganization we hope to promote a more efficient review process and create a stronger alignment of administrative, regulatory project management, program operations, policy, and drug development tool services.

Moving Forward

This reorganization is part of New Drugs Regulatory Program modernization effort, which is an ongoing, multi-phase regulatory improvement initiative comprised of structural changes, process and documentation improvements, and enhancements to administrative and regulatory operations. Modernizing our operations helps us perform our mission effectively in an environment of rapidly evolving science, changing stakeholder expectations, and new statutory authorities and responsibilities.

The reorganization, along with new processes and policies, bolsters the Center’s mission to ensure that safe, effective, high quality drugs are available for the American public. More information on implementation will be posted on the “Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality” webpage as it becomes available.