Peter Stein
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.
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Rear Admiral Richardae Araojo •
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Robyn Bent, MS, RN •
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Kevin Bugin •
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Namandjé Bumpus •
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Ashley Boam, MS •
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Diane Bruce, PharmD, RAC •
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Suranjan De •
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Michelle Campbell •
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Ethan Chen •
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John Concato •
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Jacqueline Corrigan-Curay, JD, MD •
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Christy Cottrell •
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Selena Daniels, PharmD, PhD, MS •
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Khair ElZarrad •
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Ron Fitzmartin, PhD, MBA •
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Dionna Green •
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Richard Forshee, PhD •
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Andrea Fristedt •
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Cheryl Grandinetti, PharmD •
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Karen Hicks •
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Sarah Ibrahim •
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Xianghong (Emily) Jing •
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Michael Kopcha, PhD, RPh •
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Jung Lee •
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Claudia Manzo •
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Peter Marks •
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Janet Maynard •
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Hilary Marston •
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Ann Meeker-O'Connell, MS •
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Monica Morell, PhD •
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Tina Morrison •
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Theresa Mullin, PhD •
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Monica Munoz •
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Iilun Murphy •
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Martha Nguyen •
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Steven Oh, PhD •
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Lee Pai-Scherf •
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Y. Veronica Pei •
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Ana Pineda Zavaleta, MSc •
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Andrew Potter •
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Dionne Price, PhD •
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Scott Proestel, MD •
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Francisca Reyes-Turcu •
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Stacey Ricci •
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Leyla Sahin •
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Norman Robert Schmuff, PhD •
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Kimberly Schultz, PhD •
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Haley Seymour, MS •
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Mary Ann Slack •
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Peter Stein •
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Mary Thanh Hai, MD •
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Julia Tierney •
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Melissa Torres •
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Stelios Tsinontides •
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Katherine Tyner •
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John Weiner, JD •
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Celia Witten •