Atty. Kurt R. Karst
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.
Profile Summary
About Kurt R. Karst at a glance
Kurt R. Karst is an attorney based in Washington, District of Columbia, practicing at Hyman, Phelps & McNamara PC. Admitted to practice in Maryland, Maryland State Bar Association and District of Columbia, The District of Columbia Bar. Educated at American University Washington College of Law (J.D., 2003) and Marquette University (B.A.). Recognitions include Best Lawyers in America — FDA Law (2026). Serands clients in Washington, DC and the surrounding metropolitan area.
Want to Get Service From This Attorney?
Sign up free and choose one of the two methods below.
Have a legal question? Sign up free, submit it through the Ask the Attorney module and receive a focused answer from a specialist.
- Free to ask a question
- Answers from specialist attorneys
- Optional private / anonymous question
Request an online video meeting or an in-person consultation at the attorney's office. Pick a time that works for you and share the details securely.
- Online video meeting
- In-person at the attorney's office
- Secure messaging and payment
About
- 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
Jurisdictional Context
Why local counsel matters in District of Columbia
Practicing law in District of Columbia. Legal matters in District of Columbia are governed by state-specific rules of civil and criminal procedure, statutes of limitations, and substantive law. Cases originating in Washington are typically filed in the local municipal court or the appropriate District of Columbia state district court, depending on subject matter and amount in controversy. An attorney licensed in District of Columbia brings working knowledge of local procedural deadlines, judicial practices in this andnue, and the substantive law that applies to cases brought here. Out-of-state attorneys generally cannot represent clients in District of Columbia courts without local counsel or pro hac vice admission.
Looking for additional District of Columbia attorneys? Browse all attorneys in Washington or all attorneys in District of Columbia.
Frequently Asked
Common questions about Kurt R. Karst
Where is Kurt R. Karst's law office located?
Where did Kurt R. Karst go to law school?
How can I contact Kurt R. Karst for a consultation?
What awards or recognition has Kurt R. Karst received?
Practice Areas
Education
Awards
Bar Admissions
Reviews
No reviews yet.