Key Abbreviations
The Speeches & Articles area of my website is designed as a resource for you on the wide variety of FDA legal topics
and issues that I have spoken or written about over the years.  

To locate information on a topic of interest, click on one of the
TOPICS under ARCHIVES listed to the right on
this webpage and you will be taken to a list of downloadable presentations and articles on that Topic.  
The
presentations/articles are listed in chronological order with the most recent first.

To view/download an article or presentation, just click on its title!
ARCHIVES
My Archives contain past presentations
and articles organized by subject area.
Just click on the Topic Heading below
that matches the subject that interests
you and you can obtain full text copies,
on-line, of past presentations and  
articles on key FDA regulatory law
issues.
TOPICS
Crisis Management
Food & Food Additives
Generic Drugs
For a complete list of
past presentations by
Michael Swit,
click here
Speeches & Articles -- Upcoming & Recent
© 2014 Michael A. Swit.  
ALL RIGHTS RESERVED.

Questions?

Contact me @ 760-815-4762
or
mswit@fdacounsel.com
Michael A. Swit
Upcoming Presentations
Recent Presentations and Articles
Legal Aspects of Outsourcing for Drug and Device Companies.  Outsourcing 101 Conference.  Jointly
Sponsored by OCRA and SDRAN.  November 19.  San Diego.

FDA Regulation of Social Media.  A Compliance2Go Webinar.  November 18, 2014.

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

FDA Regulation of Drug and Device Advertising & Promotion. Two-Day Course.  
ComplianceOnline.  November 6-7. 2014.  Boston.
Slides:
Understanding FDA Regulation of Mobile Medical Applications.  RAPS Annual Convention.  
September 30, 2014, Austin, Texas.

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

Crisis Management for Regulatory Professionals.  Regulatory Managers Bootcamp.  RAPS Annual
Convention.  September 28, 2014, Austin, Texas.

Clinical Trial Liability Concerns for Small Companies. Arena International’s 2nd Annual
Outsourcing in Clinical Trials Southern California, La Jolla, CA, September 23-24, 2014.

FDA Regulation of Drug and Device Advertising & Promotion.  Two-Day Course.  
ComplianceOnline.  September 11-12. 2014.  Chicago.

"Biosimilars in the U.S.: Current Status and Challenges Ahead," Generics Web INNSight, Sydney,
Australia, August 2014

Combination Products, Dietary Supplements, and Veterinary Medicine.  SDRAN RAC Review
Course.  August 13, 2014.  San Diego.

Overview of FDA Regulation of Medical Devices.  DreamIt Philadelphia Healthcare Companies.  
Webinar.  August 11, 2014.

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

History of U.S. Regulation.  OCRA RAC Review Course.  August 2, 2014.  Irvine, CA.

FDA Regulation of Labeling and Advertising, Import/Export, and Enforcement.  OCRA RAC Review
Course.  August 2, 2014.  Irvine, CA.
.
Trends in Medical Device Compliance Issues.  Medical Device & Legal Professionals: A Collaborative
Exchange.  American Bar Association and Medical Device Manufacturers Assn.  December 11-12,
2014, Washington, D.C.

FDA – Alternative Strategies in Dealing with the Agency to Develop and Gain Approval of Drugs
and Medical Devices.  A Compliance2Go Webinar.  January 29, 2015.

Key Issues in U.S. Regulation of Biosimilars.  3rd Annual BioSimilars And Follow-On Biologics 2015
Americas Conference.  Paradigm Global Events.  February 23-25, 2015.  Washington, D.C.

Orphan Drugs:  Update on U.S. Regulation.  Orphan Drugs Conference.  Informa Conferences.  
February 24-25, 2015.  London.

FDA Regulation of Mobile Medical Applications.  OCRA Annual Conference.  June 3, 2015.

Understanding the Sunshine Act.  DIA Annual Conference. Tutorial. June 15, 2015.  Washington, D.C.