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  1. Developing Products for Rare Diseases & Conditions

OOPD Leadership



Nicole Wolanski

Acting Director

CAPT Nicole Wolanski

CAPT Wolanski is the Acting Office Director and Deputy Director in FDA’s Office of Orphan Products Development (OOPD). CAPT Wolanski joined OOPD in 2017 and has over 25 years of FDA regulatory review experience and oversight knowledge. Prior to joining OOPD, she worked in the Office of Good Clinical Practice (OGCP) for two years. With her background as a biomedical engineer, CAPT Wolanski held various roles in the Center for Devices and Radiological Health before joining OGCP.CAPT Wolanski graduated from the Catholic University of America.

OOPD Managers

Henry Startzman, M.D.
Director of the Orphan Drug Designation Program

Soumya Patel, PharmD
Supervisory Secondary Reviewer, Orphan Drug Designation Program

Erika Torjusen, M.D., M.H.S.
Director of the Rare Pediatric Disease and Humanitarian Use Device Designations Program and Pediatric Device Consortia Grants Program

Katherine Needleman, Ph.D.
Director of the Clinical Trials and Natural History Grants Program

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