Archives -- Advertising & Promotion

Presentations

FDA Regulation of Drug and Device Advertising & Promotion.  Course Instructor, Two-Day Course. ComplianceOnline.  January 2013, September 2013, March 2014, March 2015, March 2016, November 2016, March 2017, November 2017.


    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
   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.


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. [video offline]

 
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]. 

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