Archives -- Generic Drugs & Biosimilars

Articles & Publications

FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do. Duane Morris Alert, November 12, 2013

Generic Drug Submissions. Chapter in Fundamentals of US Regulatory Affairs, Eighth Edition. Regulatory Affairs Professional Society.  June 2013. [out of print]

Update on Generic Biologics.  RAPS Focus 12(2),  30-35, 2007.

Hurdles on the Scientific Path to a Biogeneric Approval.  RAPS Focus 10(3):43-46, 2005.

Getting Your Generic Drug Approved.  Washington Business Information, Inc., Editor, 1995. [out of print]

Presentations & Panel Discussions

Critical Legal Issues Facing Drug GMP Compliance.  23rd Annual GMP By The Sea Conference.  August 27, 2018.  Cambridge, MD.  

Generic Drugs and Biosimilars.  Regulatory Affairs Certification (RAC) Review Course.  San Diego Regulatory Affairs Network (SDRAN).  June 14, 2018. Webinar.

What's In a Name?  FDA and Non-Proprietary Names for Biosimilars.  11th Biosimilars & Follow-On Biologics 2018 Americas.  April 20, 2018.  McLean, Virginia. 

Generic Drugs and Biosimilars. SDRAN RAC Review Course. June 16, 2016. San Diego.

ANDAs, OTCs, and Orphan Drugs. SDRAN RAC Review Course. June 24, 2015. San Diego. 

FDA Regulation of Biosimilars. San Diego Intellectual Property Law Association. February 26, 2015.  San Diego. 

U.S. Regulation of Biosimilars: Key Issues. Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence Conference.  September 2014. Austin, Texas.

ANDAs, OTCs, Orphans and Cosmetics. SDRAN RAC Review Course. August 6, 2014. San Diego. 

Generic Drug Labeling Proposed Rule: The Generic Drug Industry Perspective.  Drug Information Association (DIA) Webinar.  May 15, 2014.

U.S. Regulation of Biosimilars.  2nd Annual Biosimilars and Follow-On Biologics 2014 Americas Conference. Paradigm Global Events.  February 10-12, 2014.  Philadelphia.

Generic Drug Approvals.  Center for Professional Advancement 3-Day Course.  August 13-15, 2013.  New Brunswick, NJ.
     Introduction to Legal Basis for Generic Drugs
     The Basics of The Waxman-Hatch Act
Patent Issues and 180-Day Exclusivity

Regulation of Generic, OTC and Orphan Drugs, and Cosmetics. Lecture at SDRAN RAC Review Course.  August 7, 2013. San Diego.

GDUFA -- What Hath FDASIA Wrought?  ACI Legal & Regulatory Summit.  July 17 and 18, 2013.  New York City.

FDA Regulatory Challenges for Biosimilars and CMOs.  FierceBiotech Webinar.  June 26, 2012.

Biosimilars -- Wave of the Future or Child of the Privileged Few?  San Diego Chapter of the Licensing Executives Society.  February 21, 2012.  San Diego.

Regulation of Generic, OTC and Orphan Drugs, and Cosmetics.  Lecture at SDRAN RAC
Review Course.  July 27, 2011, San Diego.

Biosimilars -- Overview of the New U.S. Pathway.  Orange County Regulatory Affairs Discussion Group/FDA Annual Educational Conference.  June 9, 2011, Irvine, CA.

Biosimilars.  RAPS Annual Conference.  October 25, 2010, San Jose, CA.

Key Issues Impacting The Future of Biosimilars.  Foley & Lardner Life Sciences Day.  September 30, 2009, San Diego, CA.

Course on Generic Drug Approvals.  In-House at Teva Parenterals. September 1 and 2,
2009, Irvine, CA.  

      Introduction to Legal Bassis for Generic Drug Approvals

      Basics of the Waxman-Hatch Act    

      Bioequivalence & Bioavailability

Evolving Regulation of Biosimilars and Update on Generic Drug Regulation.  Orange County Regulatory Affairs Discussion Group/FDA Annual Educational Conference.  June 2009, Irvine, CA.

The Future of BioSimilars, BioGenerics, Follow-on Biologics – A Rose by any Other Name?  New York Biotechnology Association Annual Meeting.  April 21, 2009, New York.

Panel Discussion on Generic Biologics.  Licensing Executives Society, San Diego Chapter.
May 20, 2008, San Diego. [panel; no slides]

Generic Perspective on the Future of Biosimilars.  BIOCOM Life Sciences Venture Network. February 6, 2008.  San Diego.

Panel Discussion on Generic Biologics.  FDLI Annual Conference, April 12, 2007, Bethesda, MD.   [panel; no slides]

Lifecycle Management for Pharmaceutical Companies:  A Generic Perspective.  RAPS
Horizons Conference, March 29, 2007, San Francisco.

Non-Patent Market Exclusivity for Pharmaceuticals Under the Drug Price Competition and Patent Term Restoration Act of 1984 ("Waxman-Hatch").  San Diego County Bar Association, IP Section, March 19, 2007, San Diego.

Abbreviated New Drug Applications & Patent/Exclusivity Issues.  FDLI Introduction to Biotechnology Law Conference, June 15-16, 2005, San Francisco, CA.

Ethical Challenges and the Generic Drug Scandal – A Brief Retrospective.  Ethics in Regulatory Affairs, OCRA,  August 30, 2004, Irvine, CA.

ANDAs – Key Regulatory and Legislative Issues. OCRA/FDA, Annual Joint Educational Conference, June 2003, Irvine, CA.

ANDAs -- Key Regulatory and Legislative Issues.  PLI Biotechnology Law Conference.  September 19, 2002.  San Francisco, CA.

Challenges to Generic Drug Approvals.  IBC Generic Drug Conference, September 1999,
Washington, D.C. 

For information about my services for Generic Drugs & Biosimilars, ...