Highlights
Key Abbreviations
© 2014 Michael A. Swit.  
ALL RIGHTS RESERVED.

Questions?

Contact me @ 760-815-4762
or
mswit@fdacounsel.com
News Coverage and Other Key Developments
January 2, 2013 -- Michael Swit featured in interview in San Diego Union Tribune, Business
Section, page C1
.  For online version, click here...

December 2012 -- Michael Swit authors book on Good Clinical Practices: A Review of FDA’s
Enforcement Activity.  
For more info, click here...
Site Search
Michael A. Swit
Upcoming Presentations
Recent Presentations and Articles
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.
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.
.