Mr. Koustas earned his law degree with honors from American University Washington College of Law in 2008, where he served on the Administrative Law Review from 2006-2008. Mr. Koustas graduated from the University of Pennsylvania in 2004 with a Master of Biotechnology and from the University of Denver in 2003 with a B.S. in Molecular Biology. Mr. Koustas has co-authored several scientific articles on various topics in cancer research. He is admitted to practice in Colorado and the District of Columbia.
Articles / Publications
Trends in FDA's Use of Class-Wide REMS, December 2009
Search Warrants - What Happens When the FDA Storm Arrives, May/June 2009
Blog Posts
Patient Power in Orphan Drugs, January 13, 2013
Red Flags Rule Comes Back, December 5, 2012
Massachusetts Issues Final Rule on Drug and Device Manufacturer Marketing Conduct, November 27, 2012
FDA and California Board of Pharmacy Talk Pedigree at Annual HDMA Track and Trace Conference, November 18, 2012
New Track-and-Trace Legislation: The Real Deal or Another False Start?, October 25, 2012
The Regenerative Sciences - FDA Court Struggle Ends... For Now, July 25, 2012
FDA Continues Efforts to Expand Power Over Intrastate Commerce, October 26, 2011
Regenerative Sciences Lawsuit Update and FDA s Attempt to Broaden the Definition of "Interstate Commerce", October 17, 2011
Government Files Appellate Brief in Purdue Executives' Exclusion Litigation, September 20, 2011
Google to pay $500 Million Regarding Pharmacy Advertising; What is Next?, August 25, 2011
FDA Releases Opioid Class-Wide REMS, April 21, 2011
Red Flags Rule Battle Appears to Come to a Close, March 7, 2011
Regenerative Sciences - FDA Struggle Continues, January 19, 2011
Congress Passes Legislation to Alter Red Flags Rule, December 9, 2010
Confirmation Hearing for Michele Leonhart, Proposed DEA Administrator, November 18, 2010
Secure and Responsible Drug Disposal Act Passes Congress, October 3, 2010
Veterinary Compounding Pharmacy Resumes Operations Despite FDA's Attempt to Obtain a Preliminary Injunction, September 2, 2010
Regenerative Sciences Faced with FDA Injunction, August 11, 2010
FDA Releases Draft of Class-Wide Opioid REMS, July 12, 2010
Regenerative Sciences, Inc. Attempts to Avoid FDA Action, June 27, 2010
FTC Delays Enforcement of the Red Flags Rule&Again, May 28, 2010
FDA Announces a New Class-Wide REMS, February 18, 2010
Kaiser Permanente Submits Citizen Petition on REMS, January 8, 2010