BioCentury
ARTICLE | Politics, Policy & Law

Getting flatter

How FDA proposes to reorganize OND to streamline drug reviews

June 2, 2018 5:25 PM UTC

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...