CDER Delays Timetable for New Drug Office Reorganization

The FDA has pushed back its timetable for a major restructuring of the Office of New Drugs (OND), but some activities already are moving forward at the OND, including in the office that reviews cancer products.

Implementation of the OND reorganization will be delayed until summer, an FDA spokeswoman said. The drug office had hoped to implement its restructuring plan, which it announced last October, at the same time the Center for Drug Evaluation and Research moved into the FDA's new White Oak, Md., campus this spring. But the move to White Oak has been delayed, the spokeswoman said. "We still plan to move into White Oak in our new structure starting in July," she said.

When the move happens, pharmaceutical firms will likely see changes in who oversees their products at the FDA. Under the proposed reorganization, the OND will close one drug evaluation office, split a therapeutic review division, create a new review division and realign others. The goal of the restructuring is to better balance available resources and improve the logical groups of clinical indications within the OND's divisions and office structure.