Pharmacologist
US Food and Drug Administration
Megan Kelchen, Ph.D. is a pharmacologist in the Office of Research and Standards in the Office of Generic Drugs at the U.S. Food and Drug Administration. Her areas of expertise includes drug products for topical, transdermal, and mucosal drug delivery. Dr. Kelchen is responsible for the development of product-specific guidances for generic drug development, and reviewing and responding to controlled correspondences, citizens petitions, and pre-ANDA meeting requests. Dr. Kelchen is also engaged in regulatory science research initiatives related to the development of bioequivalence standards for related to topical, transdermal, and mucosal drug products through the GDUFA regulatory science research program. Prior to joining FDA, Dr. Kelchen received a Bachelor’s degree in Biology from Wartburg College and a Ph.D. in Clinical Pharmaceutical Sciences from the University of Iowa.