FDA drug center Director Janet Woodcock on Thursday (July 19) provided her staff with details on the proposed reorganization of the center, saying the plan, which has been submitted to HHS for approval, involves structural changes within the center's four offices. The key changes include: forming a therapeutic biologics and biosimilars office charged with forming biosimilar guidances and policies; shifting compounding oversight to the compliance shop's Office of Unapproved Drugs and Labeling Compliance in order to boost compounding oversight; setting...