FDA proposes process modernization to support new drug development

Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research (CDER) has proposed changes to CDER's new drug regulatory program. The proposals include regulatory and review process changes, as well as organizational restructuring.

Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research (CDER) has proposed changes to CDER's new drug regulatory program. The proposals include regulatory and review process changes, as well as organizational restructuring. "A central component of our proposed changes involves stronger integration of our talented staff so they can better work together," says Woodcock, "within and across offices, a concept we refer to as 'integrated assessment.'" Previously, CDER reviewers would seek consults from specialists in other scientific disciplines. CDER currently has 19 separate review divisions that regulate drugs. Over time, many divisions have developed procedures specific to their areas of review. Woodcock is proposing "a single and consistent process: One organization with one process." She is also proposing changes "that will increase the number of offices that oversee our review divisions from five to nine—and we're envisioning 30 review divisions within those offices—up from our current 19."