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FDA Law -- Presentations
History of U.S. Regulation. OCRA RAC Review Course. August 2, 2014. Irvine, CA.
FDASIA -- Update on FDA Implementation. American Society for Quality, San Diego
Chapter. March 12, 2013. San Diego.
FDA Update: Impact of FDASIA and the Federal Elections. SDRAN. November 15,
2012, San Diego.
Legal and Regulatory Update – FDA Developments. BIOCOM. November 13, 2012.
Review of Key 2009 FDA Law Cases. FDLI Annual Conference. April 22, 2010,
Successful FDA Meetings. Weinberg Group Webinar, March 2, 2009.
The Food & Drug Administration Amendments Act of 2007 – Understanding the Drug
Provisions. San Diego Regulatory Affairs Network. February 26, 2008, San Diego.
Legislative Initiatives -- PREA and Clinical Trial Registries. RAPS Annual
Conference, September 24, 2007, Boston.
Successful FDA Meetings. West Coast Drug Development Forum: Challenges
in the Development of Therapeutic Products. DIA, Half-Day Tutorial,
October 25-27, 2004, San Francisco.
How the “Park Doctrine” can Trigger Criminal and Civil Liability for Generic Drug -
Executives for Unknowing or Unintended FDA Violations. INNSight by GenericsWeb;
reprint of Misdemeanors Under the "Responsible Corporate Official" (RCO) Doctrine.”
Client Alert. Duane Morris LLP. August 8, 2012.
Drugs and Biologics Provisions of the Food and Drug Administration Amendments Act
of 2007. RAPS Focus 13(2), 27-33, 2007.
Western States Medical Center – Supreme Court Reins FDA in on Regulating
Commercial Speech, Drug Delivery Technology, July 2002.
Edson, J. FDLI Update, January 2001.
Profitability, Patient Populations and the Orphan Drug Act – or – “Should an Orphan
Have the Right to More Than One Parent?” Food, Drug, Cosmetic and Medical Device
Law Digest, New York State Bar Association, Food, Drug and Cosmetic Law Section,
Cosmetics Regulation. Swit, M. and Yingling, G. Chapter in Treatise on Food & Drug
Law, FDLI, 1991.
FDA Law -- Articles
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