|
|
Prior to joining the firm as an associate in 2001, Mr. Karst was a law clerk at Hyman, Phelps & McNamara, P.C. and a lobbyist for F. Hoffmann-La Roche Inc. in Washington, D.C. Mr. Karst is a 2001 graduate of the American University Washington College of Law, and holds a Bachelor of Arts degree in political science and German from Marquette University (1995 magna cum laude). Mr. Karst served as an articles editor for the American University Law Review, and in 1995, was awarded a Fulbright Scholarship for post-graduate studies in Germany. He has published in the American University Law Review, the Food and Drug Law Journal, FDLI Update, and is co-author of the Food and Drug Law Institute's Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives. He is admitted to practice law in the District of Columbia and Maryland.
Articles / Publications
FDA Amendments Act - HPM Issues Detailed Summary and Analysis,
October 2007
FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to Patients,
December 12, 2006
Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill,
September 29, 2006
FDA's Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?,
August 11, 2006
New Law Reins in "Authorized Generics" Despite Generic Industry Court Losses, But Leaves Several Ambiguities,
June 2006
District Court Rules on Simvastatin 180-Day Exclusivity,
May 5, 2006
FDA Issues Long-Awaited Prescription Drug Labeling Regulations,
January 26, 2006
FDA's Unauthorized User Fee Money Grab,
August 12, 2005
FDA Draft Guidance on Exploratory IND Studies,
April 22, 2005
FDA Issues Good Review Management Principles and Practices Guidance Document,
April 22, 2005
How FDA's New Labeling Rule Could Preempt State Law
Comments, Pediatric Testing of Prescription Drugs: The Food and Drug Administration's Carrot and Stick for the Pharmaceutical Industry
|
