Caroline Strasinger PhD

Dr. Strasinger is a Master Reviewer of Chemistry, Manufacturing and Controls in the Office of Pharmaceutical Quality and is Chair of the FDA’s Transdermal Drug Working Group (TDWG). As Chair she is responsible for assuring the TDWG fulfills their mission to the Center for Drug Evaluation and Research (CDER) of continuously improving the scientific premises for regulating product quality as it relates to the clinical performance and public availability of transdermal and topical delivery systems and related drug products. She began her career at FDA in 2009 in the Office of New Drug Quality Assessment and during her tenure has received numerous awards, published in scientific journals, and co-authored several guidances, including the 2019 Draft Guidance For Industry Transdermal and Topical Delivery Systems –Product Development and Quality Considerations. Dr. Strasinger has represented the Agency at multiple national and international meetings both for her work as a regulatory reviewer and as Chair of the Transdermal Drug Working Group. She received her PhD in Pharmaceutics and a Bachelors Degree in Chemical Engineering from the University of Kentucky.