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Generic Drugs & Biosimilars -- Presentations
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Archives -- Generic Drugs & Biosimilars
Generic Drugs & Biosimilars -- Articles
Biosimilars in the U.S.: Current Status and Challenges Ahead.  Swit, Michael and Klein,
Alan.  INNSight by GenericsWeb Article.  August 2014.

There May Be A Paradigm Shift in U.S. Generic Drug Labeling.  INNSight.  A
GenericsWeb Publication. November 2013.

"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.

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.
© 2014  Michael A. Swit.  
ALL RIGHTS RESERVED.

Questions?

Contact me @ 760-815-4762
or
mswit@fdacounsel.com
Update on U.S. Regulation of Biosimilars.  RAPS Annual Convention.  September 29,
2014, Austin, Texas.

ANDAs, Orphan Drugs, OTC Drugs and Cosmetics.  SDRAN RAC Review Course.  
August 6, 2014.  San Diego.

U.S. Regulation of BioSimilars.  2nd Annual Biosimilars And Follow-On Biologics 2014
Americas Conference. February 10-12, 2014.  Philadelphia.

Generic Drug Approvals.  Center for Professional Advancement 3-Day Course.  August
13-15, 2013.  New Brunswick, NJ.

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

The Gamechanger:  The Impact of the Generic Drug User Fee Act.  ACI Legal &
Regulatory Summit.  July 17 and 18, 2013.  New York City.

Regulation of ANDAs, Orphan Drugs, OTC Drugs and Cosmetics.  SDRAN RAC
Review Course.  August 1, 2012.  San Diego.

Biosimilar Regulation and CMOs.  FierceBiotech Webinar.  June 26, 2012.
Regulation of Generic, OTC and Orphan Drugs, and Cosmetics.  Lecture at SDRAN
RAC Review Course.  July 27, 2011, San Diego.

BioSimilars.    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.

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.  
Three presentations:  (1)  Introduction to Generic Drug Law  (2)
Basics of Waxman-Hatch  (3) Bioequivalence

Update on Generic Drugs and BioSimilars  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]

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.  FDLI Introduction to Biotechnology Conference,
June 14-15, 2005, San Francisco, CA.

Case Study:  The Generic Drug Scandal.  Ethics in Regulatory Affairs, OCRA,
August 30, 2004, Irvine, CA.

Recent Developments in Generic and OTC Drug Regulation. OCRA/FDA, June 2003
Annual Joint Educational Conference, Irvine, CA.

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