Robert T. Berendt PhD

Dr. Robert Berendt is a branch chief in the Office of Lifecycle Drug Products within the FDA's Office of Pharmaceutical Quality, where he specializes in the quality assessment of modified-release drug products, including transdermal systems and topical delivery systems. Previous work in CDER has included primary quality assessment of ANDAs for injectables, solid orals (IR and MR), and transdermal systems; and he supported regulatory review and policy activities for three years as a pharmaceutical scientist in the FDA laboratories at White Oak. He earned his doctorate in pharmaceutical chemistry from the University of Kansas. His dissertation research focused on the solid-state characterization of pharmaceutically relevant systems, and he specialized in the application of solid-state NMR spectroscopy to understand the crystallization of small-molecule drug substances. He is a member of the CDER Transdermal Working Group and the CDER Excipients Working Group, and he maintains a research interest in the solid-state chemistry of drugs.