Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, presented plans for reorganizing the Office of New Drugs at a town hall meeting of all CDER staff on Friday. Woodcock has been serving as acting OND director since the former director, John Jenkins, left the agency in January 2017.
The reorganization, which is subject to congressional approval, includes the addition of 11 new review divisions, bringing the total number of divisions with responsibility for new drug reviews to 30. They would be clustered under nine offices.
In addition to the structural changes, Woodcock announced process changes, investments in IT, and other steps that are expected to cut about 20% off the time required to review a new drug application. She said OND staff will use the saved time to increase their engagement with the world outside FDA’s campus, especially with patients, caretakers and their advocates, as well as with drug sponsors and the academic community (see BioCentury, June 2).