Ensuring Compliance with FDA Requirements for Advertising
& Promotion of Drugs & Medical Devices.
Two-Day Course, sponsored by ComplianceOnline.  

March 22-23, 2018.  San Francisco, CA.  

For more info, click here

FDA Initiatives on Naming/Suffixes for Biosimilars

Biosimilars & Follow-on Biologics 2018 Americas

Paradigm Global Events

April 19-20, 2018.  McLean, VA

For more info, click here 

FDA Inspections: Handling the Consequences. 

MAGI's Clinical Research Conference

May 20-23, 2018.  Arlington, VA.

For more info, click here

Critical Legal Issues Facing GMP Compliance.  

23rd Annual GMP By The Sea Conference.  

August 27-29, 2018.  Cambridge, MD.
For more info, click here


The Application Integrity Policy (AIP):  A Little History.  
Webinar presentation sponsored by Food & Drug Law Institute (FDLI).

March 13, 2018

EU MDR & IVDR Implications for Manufacturers & Suppliers.
Moderator, Panel Discussion, at MD&M West, 

February 7, 2018, Anaheim, CA.  

[no slides; moderator]

The Application Integrity Policy (AIP):   A Little History.    

Presentation to the Food & Drug Law Institute Annual Enforcement, Litigation & Compliance Conference for the Drug, Device, Food, and Tobacco Industries. 

December 5, 2017.  Washington, D.C. 


FDA Regulation of Drug and Device Advertising & Promotion.  

Course Instructor, Two-Day Course. ComplianceOnline.  

November 9-10, 2017. Boston, MA.

Part 1:  Basics

     Part 2:  Direct-to-Consumer Advertising

Part 3:  Scientific Dissemination  

     Part 4:  FDA Enforcement

Part 5:  Social Media & Internet  

Part 6A:   Guidance on Medical Product Communications Consistent with Labeling

     Part 6B:  First Amendment, Off-Label & False Claims
Part 7:  FTC Regulation

     Part 8:  Handling at Company Level


Jan. 2013 -- SD Union Tribune Interview of Michael Swit (pdf)


Jan. 2003 -- SD Union Tribune Profile of Michael Swit (pdf)