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Archives -- Drugs & Biologics
Get to the Clinic on Time.  Regulatory/Reimbursement Panel.  The NIH-CAP Commercialization
Training Workshop.  LARTA.org.  November 10, 2014.  Los Angeles.  
[no slides]

Update on U.S. Regulation of Biosimilars.  RAPS Annual Convention.  September 29, 2014, Austin,
Texas.

Leaping the Valley of Death:  Keys to Going from the Lab to the Clinic.  Moderator. DIA Annual
Conference, June 17, 2014.  San Diego. [no slides; moderated panel]

Orphan Drug Regulation. 2nd Annual Orphan Drugs Research & Commercialization Conference.
GTCBio.  Feb. 20-21, 2014. San Diego, CA. [no slides; panel discussion].

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

Creative Strategies in Dealing With FDA.  PSC Creative Learning Webinar.  July 10, 2013.

Creative Strategies in Dealing with FDA.  Compliance2Go. Webinar.  February 21, 2013.

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.

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

Get to the Clinic on Time. LARTA NIH-CAP Commercialization Workshop, November 1, 2011. Los
Angeles.

Challenges of Orphan Drug Regulation.  The Weinberg Group Inc. Webinar, February 23, 2011.

Drug Development in Today's Regulatory Environment.  NanoTecNexus Webinar.  March 4, 2010.

Regulatory Pitfalls in Drug Development.  American Chemical Society, San Diego Chapter.  
November 18, 2009, San Diego.

Drug Safety.  SDRAN/OCRA Drug Development Conference.  November 4, 2009, Carlsbad, CA.

Regulatory Update.  Ophthalmic Drug and Delivery Summit. Pharmaceutical Education Associates.  
September 22, 2009, San Diego.

Drug Development.  Moderator, Biotech Vendors Services.  July 22, 2009, San Diego. [no slides]

Drug Safety.  Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference.  June
10, 2009, Irvine, CA.  

Regulatory Developments for Drug Delivery.  Third Annual Drug Delivery Summit.  Arrowhead
Conferences. May 14, 2009, San Francisco.

Drug Safety:  Perspectives on Industry's Duties in the Post-Vioxx Age.  FDLI Annual Conference.  
April 22, 2009, Washington, D.C.

Regulatory Aspects of Ophthalmic Drug Development.  Pharmaceutical Education Associates
Ophthalmic Drug Delivery Conference.  September 22-24, 2008, San Diego.

Clearing the US and EU Regulatory Path to Product Approval.  Swedish American Chamber of
Commerce.  Swedish-American Entrepreneurial Days. April 9, 2008, San Diego.

Keynote Presentation on FDA Regulatory Developments.  Pharmaceutical Education Associates’ 2nd
Annual Skin Summit Conference, February 20, 2008, Philadelphia.

International Drug Development. Pharmaceutical Education Associates Pipeline to Product
Conference, November 30, 2007, Alexandria, VA.

Regulatory Pitfalls in Drug Development. Pharmaceutical Education Associates Pipeline to Product
Conference, November 30, 2007, Alexandria, VA.

Keynote Presentation on FDA Regulatory Developments. Pharmaceutical Education Associates
Annual Nasal Drug Delivery Conference, October 4, 2007, Philadelphia.

FDA Regulatory Developments.  Keynote Presentation at Pharmaceutical Education Associates
Annual Ophthalmic Drug Delivery Conference, September 10, 2007, San Diego.

Keynote Presentation on FDA Regulatory Developments.  Presented at the  Pharmaceutical Education
Associates Annual Drug Delivery Conference, June 6, 2007, San Diego.

The Impact of the Democratic Congress on the Biotech Industry.  Moderated Panel at the BayBio
Annual Meeting, April 26, 2007, San Francisco. [panel; no slides]

Alternative Approaches to Drug/Biologics Approvals.  SDRAN, November 28, 2006, San Diego.

Strategies in Designing Clinicals for Fixed-Combination Drugs.  DIA Annual Meeting, June 19, 2006,
Philadelphia.

California Stem Cell Research And Cures Act.  RAPS West Coast Conference & Exhibition, March 22-
24, 2005, San Francisco, CA.

Strategies in Designing Clinicals for Fixed-Combination Drugs.  Combination Drug Development
Conference sponsored by Barnett International Conferences, March 7-8, 2005, San Diego, CA.

FDA Legal and Regulatory Strategies for Start-up Companies.  Tech Coast Angels, BioMedTrak
Program
, March 2003, La Jolla, CA.
Biosimilars in the U.S.: Current Status and Challenges Ahead.  Swit, Michael and Klein, Alan.  INNSight by
GenericsWeb Article.  August 2014.

Two Federal Appeals Court Proceedings May Impact Patent and Regulatory Strategies for Developers of
Stem Cell Technologies.  Duane Morris Life Sciences Law Blog.  February 11, 2014.

FDAAA – An Abbreviation in Search of Understanding:  A Review of Selected 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.

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

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Contact me @ 760-815-4762
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mswit@fdacounsel.com
Michael A. Swit