Archives -- FDA Law

Publications

Collateral Consequences of Violating the Federal Food, Drug, and Cosmetic Act.  Chapter 15, Pharmaceutical Compliance and Enforcement Answer Book.  The Practicing Law Institute (PLI).  June 2018.    

    • To see outline of Chapter 15, click here.  

    •  For ordering information, click here.


D.C. Circuit Affirms HHS Power to Disqualify Corporate Officials Convicted 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, 2008.


Western States Medical Center – Supreme Court Reins FDA in on Regulating Commercial Speech. Drug Delivery Technology, July 2002.


Electronic Signatures Act – Feast or Famine for FDA-Regulated Industries?  Swit, M and Edson, J.  FDLI Update, January 2001. [reprint unavailable]


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, January 1992.


Cosmetics Regulation.  Swit, M. and Yingling, G.  Chapter in Treatise on Food & Drug Law, FDLI, 1991. 

Presentations & Panel Discussions

U.S. -- History of Regulation.  Orange County Regulatory Affairs (OCRA) Discussion Group Regulatory Affairs Certification (RAC) Review Course.  August 2, 2014.


The Impact of FDASIA on the Drug and Device Industries.  American Society for Quality, San Diego Chapter. March 12, 2013.  San Diego.


FDA Update:  Impact of FDASIA and the Elections. SDRAN. November 15, 2012, San Diego.


FDA Update.  BIOCOM Reimbursement and Market Access Series. November 13, 2012.  San Diego.


Review of Key 2009 FDA Law Cases.  FDLI Annual Conference. April 22, 2010, Washington, D.C.


FDA Law and Regulatory Affairs.  Keck Graduate Institute. October 7, 2009, Pomona, CA.


FDAAA -- An Abbreviation in Search of Meaning:   Impact of the Food & Drug Administration Amendments Act of 2007 on the Drug and Biologics Industries.  San Diego Regulatory Affairs Network. February 26, 2008, San Diego.


Legislative Initiatives -- Pediatric Research and Clinical Trial Registries/Databases.  RAPS Annual Conference. September 24, 2007, Boston. 

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