Janet Woodcock1, Peter Stein2, Kevin Bugin3. 1. Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland. 2. Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland. 3. Special Programs, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.