Congress has given the go-ahead for a restructuring aimed at improving CDER’s new drug reviews.
The first phase will help CDER keep up with the changing needs of new drug reviews by boosting its review divisions and allowing them to specialize in certain drug types.
Specifically, the Office of New Drug (OND)’s divisions and offices will be categorized by therapeutic area to help balance the burden of reviews. The number of clinical offices that handle review divisions will be increased from six to eight, and the number of clinical divisions will increase from 19 to 27. In addition, six divisions of pharmacology/toxicology will be added.
Three new offices will also be established: an Office of Program, Administrative, and Regulatory Operations; an Office of New Drug Policy; and an Office of Drug Evaluation Sciences.