FDA CDER Reorganization Aims to Improve Drug Approval Process

FDA Unveils Reorganization of Office of New Drugs

The U.S. Food and Drug Administration (FDA) has unveiled a reorganization of the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER), coupled with corresponding changes in the Office of Translational Sciences and Office of Pharmaceutical Quality.

The approved changes in OND will create offices that align interrelated disease areas and divisions with clearer and more focused areas of expertise—designed in part to help speed the clinical trial process. The changes increase the number of OND offices that oversee agency reviews from six to eight—and increase the number of OND clinical divisions from 19 divisions to 27; they also add six non-clinical review divisions.

“In addition to enabling greater efficiency, these envisioned changes will help us to better understand the diseases intended to be treated by the drugs we evaluate for approval—another way we aim to enhance our scientific leadership,” FDA said in a statement.

OND will also create cross-functional support offices of New Drug Policy, Drug Evaluation Sciences, Therapeutic Biologics and Biosimilars, Regulatory Operations, Program Operations, and Administrative Operations.

The reorganization is an offshoot of FDA’s 2017 CDER initiative to modernize the New Drugs Regulatory Program.  For more information on the overall program, go to Modernizing FDA’s New Drugs Regulatory Program.

Author: Michael Causey