D. Elizabeth McNeil

National Institutes of Health - NIH

Position in Extended Committee - Regulatory Expert

Elizabeth has been a medical officer at the US Food and Drug Administration (FDA) since 2002.  She is a board-certified pediatric neurologist and was a primary reviewer and then team leader for neuromuscular diseases in the neurology review division at the FDA before joining the Office of Orphan Product Development. While at the FDA, her review experience has included primary reviews for orphan drug designation reviews, New Drug Applications (NDA)/efficacy supplement reviews, phase III protocol reviews (including special protocol assessments) and numerous commercial/non-commercial Investigational New Drug (IND) reviews.

She has worked extensively on a full range of products, including new molecular entities, new formulations of approved drug products, drug-drug combinations, and drug-device combinations. She has worked to develop new scientific, clinical and regulatory standards for the development of certain drug classes. Her initiatives have resulted in standardization and clarification of terminology used in defining claims and endpoints, as well as in increased standardization, precision, and sensitivity in reporting safety and efficacy data.

NINDS Office of Clinical Research
Neuroscience Center, Room 2215
6001 Executive Blvd., MSC 9520
20892 (for courier, use Rockville, MD 20852)
Bethesda, MD
20892
United States of America

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