Curriculum Vitae
Full Name Caroline Strasinger
Position / Job Title Office of Pharmaceutical Quality/Master Reviewer
Affiliation U.S. Food and Drug Administration
Email Caroline.strasinger@fda.hhs.gov
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has received numerous awards, published in scientific journals, and co-authored several guidances, including the 2019 Draft Guidance For Industry Transdermal and Topical Delivery Systems –Product Development and Quality Considerations (https://www.fda.gov/media/132674/download). 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.

Recent Publications:
1. Nicole Brogden, Caroline Strasinger, et. al, “Determination of rate and extent of scopolamine release from Transderm Scop® transdermal drug delivery systems in healthy human adults.” AAPS PharmSciTech (2020 - Accepted).
2. Loqman A Mohamed, Caroline Strasinger, et. al, “Drug recrystallization in drug-in-adhesive transdermal delivery system: A case study of deteriorating the mechanical and rheological characteristics of testosterone TDS.” International Journal of Pharmaceutics (2020).
3. Teng Xu, Huzeyfe Yilmaz, Daniel Willet, Caroline Strasinger, et. al, “Raman mapping of fentanyl transdermal delivery systems with off-label modifications.” Analyst (2019).
4. Soo Hyeon Shin, Caroline Strasinger, et. al, “The Sensitivity of In Vitro Permeation Tests to Chemical Penetration Enhancer Concentration Changes in Fentanyl Transdermal Delivery Systems.” AAPS PharmSciTech (2018).
5. Caroline Strasinger “FDA Review of Drug Products That Employ Transdermal or Topical Delivery Systems.” FDA Briefing Document: Pharmacy Compounding Advisory Committee (PCAC) Meeting. (2016).
6. Caroline Strasinger, Sam Raney, et. al. “Navigating Sticky Areas in Transdermal Product Development.” J. Controlled Release (2016).
7. Anna M. Wokovich, Caroline Strasinger, et.al, “Cold Flow Measurement of Transdermal Drug Delivery Systems (TDDS).” J. of Adhesion & Adhesives (2015).