Kurt Karst

Practice Areas

Kurt Karst counsels pharmaceutical and biotechnology companies on FDA regulatory issues relating to drug development, approval, exclusivity, and lifecycle management. His practice focuses on Hatch-Waxman matters, Orange Book patent listings, orphan drug issues, pediatric exclusivity, regulatory exclusivity, and post-approval compliance considerations.

He advises manufacturers on strategic issues arising throughout the drug development process, including investigational programs, new drug applications, abbreviated new drug applications, exclusivity disputes, and regulatory pathways for innovative and generic products. He is also known for his work on orphan drug designation and broader product lifecycle strategies.

Career

Kurt Karst is a Director at Hyman, Phelps & McNamara and a leading practitioner in the field of pharmaceutical regulatory law. He is a co-founder and primary author of the FDA Law Blog and has extensive experience advising pharmaceutical manufacturers on Hatch-Waxman and exclusivity issues. His practice encompasses regulatory strategy, drug development, marketing matters, and interactions with the FDA concerning approval and exclusivity determinations.

Education