How FDA proposes to reorganize OND to streamline drug reviews
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, brought the center’s entire staff of about 5,000 people together in the agency’s Great Room on June 1 for a town hall meeting to roll out a proposed reorganization of the way the agency reviews new drugs. The changes she described to the Office of New Drugs (OND) could make reviews dramatically more efficient and consistent, and enhance the scientific expertise and stature of its scientists and physicians.
Woodcock told her staff that anticipated efficiencies resulting from workflow changes and new technologies will allow them to carve out more time to interact with the world outside FDA’s campus.
OND’s organization would become flatter, with the addition of new disease-focused divisions clustered into offices aligned with those same diseases.
To understand, facilitate and lead the scientific progress that is propelling medical advances, she wants CDER staff to up their engagement with academic researchers, the pharmaceutical industry and regulatory agencies in other countries. She also emphasized the