Kurt R. Karst

Kurt R. Karst


Hyman, Phelps & McNamara, P.C.

Recognized since 2021

Washington, District of Columbia

Practice Areas

FDA Law

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Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the co-founder and primary author of Hyman, Phelps & McNamara's FDA Law Blog, Mr. Karst often leads the response to new rules and regulations, sharing his interpretation with the broader legal community.

Mr. Karst's knowledge of FDA precedents and timely analysis of developments helps clarify and shape the industry's understanding of Hatch-Waxman, in particular. He is a prolific writer, contributing to the blog and publishing articles in major legal journals. Mr. Karst has co-authored and contributed to several text books, including Generic and Innovator Drugs: A Guide to FDA Approval Requirements;Pharmaceutical, Biotechnology, and Chemical Inventions; Fundamentals of US Regulatory Affairs; and FDLI's Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives.

Mr. Karst clerked for Hyman Phelps & McNamara while attending law school and served as articles editor for the American University Law Review. Before joining the firm, Mr. Karst lobbied for F. Hoffmann-La Roche Inc. In 1995, he was awarded a Fulbright Scholarship for post-graduate studies in Germany.

Location
  • 700 Thirteenth Street, NW, Suite 1200
    Washington, DC 20005
Education
  • Marquette University, B.A.
  • American University Washington College of Law, J.D., graduated 2003
Bar Admissions
  • Maryland, Maryland State Bar Association
  • District of Columbia, The District of Columbia Bar

Hyman, Phelps & McNamara, P.C.
Headquarters: Washington, District of Columbia

13 The Best Lawyers in America® awards

3 Best Lawyers: Ones to Watch® in America awards

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Recognized in The Best Lawyers in America® 2025 for work in:
  • FDA Law

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