Beth Duvall is the Associate Director for Regulatory Affairs in the Office of New Drugs Immediate Office (OND IO), Center for Drug Evaluation and Research (CDER), FDA. She manages a team of regulatory project managers and support staff responsible for implementing and overseeing pediatric and maternal health initiatives, and for providing support and oversight for the DARRTS Program, Postmarketing Requirements/Commitments (PMR/PMC) Program, Formal Dispute Resolution, Rare Diseases, Guidance and Policy Team, Safety Policy and Research Team, OND Process Improvements, and other cross-cutting initiatives within OND. She is also the lead facilitator of the 505(b)(2) clearance and coordinating committees. Prior to joining the FDA, Ms. Duvall was employed at E.I. DuPont de Nemours and Company (Wilmington, DE) as a Research Technician. She joined the FDA in 1996 as a Regulatory Project Manager in the Division of Anti-Infective Drug Products (CDER/OND) where she worked until joining OND IO in 2003 as the PMR/PMC Program Manager, followed by a Team Leader role in 2006, and finally her current role in 2011. Ms. Duvall earned a B.S. Degree in Chemistry (minor in mathematics) from the University of Delaware. She is an Excellence in Government senior fellow (2008).