CDER review management
This article was originally published in The Rose Sheet
Executive Summary
Drug center Director Janet Woodcock, MD, takes on additional role as acting director of CDER's Office of Review Management following the resignation of Murray Lumpkin, MD. Lumpkin will remain at FDA "on detail to a deputy center director position for the next several weeks to assist me in the ORM transition," Woodcock told CDER staff in an Oct. 13 memo. During that time, Lumpkin will evaluate "various options outside the center." His resignation was for personal reasons, according to the memo. During his tenure as the ORM head, Lumpkin contributed to the creation and ongoing implementation of the OTC labeling reg