Archives -- Advertising & Promotion

Articles

FDA Regulations and Enforcement Actions Relative to Oversight of Advertising and Promotion.  Chapter 4, Pharmaceutical Compliance and Enforcement Answer Book.  The Practicing Law Institute (PLI).  June 2018.    

     • To see outline of Chapter 4, click here.  

     •  For ordering information, click here.


Western States Medical Center – Supreme Court Reins FDA in on Regulating Commercial Speech. Drug Delivery Technology, July 2002.  

Presentations & Panel Discussions

Basics of FDA Regulation of  Device & IVD Advertising  

                   and

FDA Regulation of Advertising  of  Diagnostics, RUO Products, and  Laboratory Developed Tests.

FDLI Advertising & Promotion Conference. October 16, 2018.  Washington, D.C.


Scientific Exchange:  New Interpretations??  Drug Information Association (DIA)  AdPromo Working Group.  Webinar.  July 25, 2018.


Ensuring Compliance with FDA Requirements for Advertising  & Promotion of Drugs & Medical Devices.  Course Instructor, Two-Day Course. ComplianceOnline.  March 22-23, 2018.  San Francisco, CA.  (same course given multiple times since January 2013). 


  Slides: 

     Part 1:  Basics

     Part 2:  Direct-to-Consumer Advertising

     Part 3:  Scientific Dissemination  

     Part 4:  FDA Enforcement

     Part 5:  Social Media & Internet  

     Part 6:   First Amendment, Off-Label & False Claims; Guidance on Medical Product Communications Consistent with Labeling 

     Part 7:  FTC Regulation

     Part 8:  Handling at Company Level


A Practical Look at Legal & Regulatory Issues in Promoting Diagnostics and Related Products. Advertising & Promotion Conference.  FDLI.  September 27, 2016.  Washington, D.C. [slides not available]


FDA Regulation of the Internet and Social Media.  Compliance2Go Webinar.  November 17, 2015.  


Internet Issues for FDA-Regulated Industry – A Review of Issues Involving Social Media.  Compliance2Go Webinar.  November 18, 2014. 


Labeling/Advertising and Promotion, Import/Export, and Enforcement Actions. Regulatory Affairs Certification (RAC) Review Course. OCRA.  August 2, 2014.  Irvine, CA.

 

FDA Regulation of Social Media. MetricStream Webinar. November 6, 2013.

FDA Regulation of Social Media. OCRA/FDA Joint Educational Conference.  June 12,
2013.  Irvine, California.

Key Issues in FDA Regulation of Advertising and Promotion -- Video Interview of Michael A. Swit. ComplianceOnline.  May 7, 2013. 

 
FDA Regulation of Social Media.  Compliance2Go. Webinar.  November 27, 2012.

Internet Issues for Regulatory Professionals -- FDA Regulation of Social Media.  Orange
County Regulatory Affairs Discussion Group.  April 17, 2012, Irvine, CA.

Medical Device Advertising.  IVT Medical Device Conference, August 15-17, 2006, San Francisco.

Problems Faced by Device Companies in Navigating FDA Promotional Issues.  Panel Discussion at the Wilson Sonsini Goodrich & Rosati Medical Device Conference, June 15, 2006, San Jose, CA.  [panel; no slides]

Using Clinical Studies to Support Claims for 510(k) Devices.  RAPS Advertising, Promotion and Labeling Conference, May 2, 2006, Denver.

FDA Regulation of Advertising and Promotion. OCRA, Irvine, California, September 2003.

Legal Issues in Drug Sampling. Audioconference, FDANews.com, November 2002 [no slides available]. 

For information on my services relating to Advertising & Promotion, ...