The US Food and Drug Administration (FDA; Rockville, MD) took about 16 months to approve new molecular entities (NMEs) in 2000, up from 12 months in 1999 according to the Center for Drug Evaluation and Research's (CDER; Rockville, MD) 2000 Report to the nation released on April 27. However, CDER Director Janet Woodcock attributes the increase in approval time to seven historically tardy products that all happened to be approved in 2000, dismissing the notion of a trend. However, in April, pending approvals of at least three NMEs under review at the FDA's Center for Biologic Evaluation and Research—Amgen's (Thousand Oaks, CA) new anemia drug Aranesp, Idec's (San Diego, CA) cancer monoclonal antibody Zevalin, and Genentech's (S. San Francisco, CA) asthma therapeutic Xolair—were pushed back a full quarter, significantly lowering investor earnings estimates. Such delays can result in lost profits and decreased patent protection time, which begins at filing. Meanwhile, FDA expects its plan to accept electronic submissions of any record by 2002, to increase efficiency of review times.