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Understanding the Food and Drug Administration’s Guidance on Direct-To-Consumer Television Advertisements
   LIVE Webcast  

 


Event Details:                                                                                                                                                          

The Food and Drug Administration recently issued draft guidance to explain its approach to pre-dissemination review of direct-to-consumer (DTC) television advertisements. The draft guidance represents a significant change in FDA’s approach and attempts to provide detail on what steps advertisers should take and what enforcement steps, including civil and criminal penalties, may be expected.. If adopted, the Guidance will present significant compliance challenges for all companies in the industry.

Pharmaceutical companies and ad sponsors should have a complete understanding of FDA’s current thinking as reflected in this draft guidance to assess its potential impact on their business relations.

The Knowledge Group has assembled a panel of distinguished professionals and key regulators to help understand the complex issues related to the draft guidance and its impact on your firm and the broader market. The speakers will present their expert opinions in a two-hour LIVE Webcast.

Course Level: Intermediate
Prerequisite: None
Method Of Presentation: Group-Based-Internet
Developer: The Knowledge Group, LLC
Recommended CLE/CPE Hours: 1.75 - 2.0
Advance Preparation: Print and review course materials
Course Code: 124324
Recording Fee: $299 (Please click here for details)

 

Featured Speakers for Understanding the Food and Drug Administration’s Guidance on Direct-To-Consumer Television Advertisements LIVE Webcast :


Agenda  (click here to view more)


I. DTC Regulation
  • A. Jurisdiction
    • 1. FDA & FTC
    • 2. State authorities
  • B. The Draft Guidance
    • 1. Categories of television ads covered
    • 2. The 45-day pre-dissemination submission
  • C. Comments from Industry
II. DTC in State and Federal Courts – WALSH
  • A. Constitutional issues
    • 1. Commercial speech and compelled speech – First Amendment
    • 2. Due process and vagueness – Fourteenth Amendment
  • B. Tort claims
    • 1. The learned intermediary doctrine
    • 2. Off-label promotion
  • C. Preemption
III. DTC Compliance – HURON
  • A. Planning the 45-day pre-dissemination submission
  • B. Implementing requests for changes
IV. DTC Enforcement – ENGELMANN
  • A. FDA –Options
    • 1.Untitled Letter
    • 2. Warning Letter
    • 3.CMP’s
  • B. Competitors
    • 1. Complaints
    • 2. Litigation (Lanham Act)
  • C. Plaintiffs’ Litigation
  • D. Interplay with CIA’s/StateSettlements




Strasburger & Price, LLP
Michael A. Walsh
Partner
speaker bio »»

Huron Consulting Group
Mark A. DeWyngaert PhD
Managing Director
speaker bio »»

Huron Consulting Group
Brad Dawson
Director
speaker bio »»

McDermott Will & Emery
Glenn M. Engelmann
Senior Counsel
speaker bio »»



Who Should Attend?

- Bio/Pharma and Related Attorneys
- Advertising Attorneys
- Health Care Law Attorneys
- Health Industry Advisors
- Health Policy Directors
- Compliance Officers
- State Health Executives/Professionals
- General Counsel
- Senior Management
- Senior Executives
- Advertising/Marketing Officers
- Professionals coming from Food and Drug Industries
- Consultants & Clients in the Food and Drug Industries

Why Attend?

This is a must attend event to everyone to hear the up-to-the minute updates, issues and developments concerning the draft guidance on direct-to-consumer (DTC) advertisements.

- New guidance explained by the most qualified key leaders & experts
- Hear directly from experienced practitioners & thought leaders
- Interact directly with panel during Q&A

Enroll in this course today by clicking the Register button below. Space is limited and discounts apply for early registration.

Registration Information:                                                                                                                                    


(Click here for information on group registrations and discounts)

Disclaimer:
Please note, the event date is firm although it may be subject to change. Please click here for details.
The Knowledge Group, LLC is producing this event for information purposes only. We do not intend to provide or offer business advice. The contents of this event are based upon the opinions of our speakers. The Knowledge Congress does not warrant their accuracy and completeness. The statements made by them are based on their independent opinions and does not necessarily reflect that of The Knowledge Congress' views. In no event shall The Knowledge Congress be liable to any person or business entity for any special, direct, indirect, punitive, incidental or consequential damages as a result of any information gathered from this webcast.

 

 

 

 

 

 

 

 

 

 

 

 


Understanding the Food and Drug Administration’s Guidance on Direct-To-Consumer Television Advertisements
LIVE Webcast
Event Sponsors / Speaker Firms:




Strasburger & Price, LLP is an AmLaw 250 law firm offering clients a broad range of legal services in over 30 practice areas. The firm represents international, national and middle market Texas-based companies with the goal of finding effective business solutions while complying with the highest standards of character, professionalism and understanding. To learn more Strasburger's rich history, diverse areas of practice and experienced attorneys, visit www.strasburger.com.




Huron Life Sciences assists the continuum of life sciences organizations from pharmaceutical companies and device manufacturers, to academic medical centers and hospitals, to universities and research institutes, to the law firms and other organizations that support the life sciences industry. Our team is comprised of experienced consultants and subject matter experts with many years of business, scientific, industry, and regulatory experience. We help our clients improve their regulatory compliance, increase efficiencies in their clinical research enterprises, and achieve their financial and operational objectives. For more information, please visit www.huronconsultinggroup.com.




McDermott Will & Emery has one of the largest and most prestigious Health law practices in the world, counseling leading organizations in every major sector of the health and life sciences industry on legal, regulatory and business transaction issues. For the second consecutive year Chambers USA ranked the Firm's Health practice as the only Tier 1 Health Practice in the United States. The Firm’s Life Sciences Industry Group is also nationally ranked by Chambers USA, and this group of 135+ lawyers, patent agents and scientific advisors provides the full range of legal services required by life sciences companies, regardless of their stage of development.




 

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Attention New York Attorneys:

This program is approved for CLE credit under New York’s Approved Jurisdiction policy. The Knowledge Group, LLC is an approved sponsor in the state of California, a New York Approved Jurisdiction. This program fulfills the non-traditional format requirement of exceeding 60 minutes in length. Please note only experienced attorneys (more than 2 years) are eligible to receive CLE credit via non-traditional format learning platforms. The Knowledge Group will verify attendance during the webcast via secret words (3 per credit hour) and by auditing attendees log in and log out records. All verification instructions will be provided during the webcast. Once attendance verification requirements have been completed, the attendee will be issued a certificate of attendance be The Knowledge Group for the course with the recommended number of credit hours. The Certificate of Attendance is normally sent via email in 24 hours or less.

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The attorney should simply include credits earned via Knowledge Group webcasts when computing the total number of CLE credits completed, and keep the Knowledge Group Certificate of Attendance for a period of at least four (4) years in case of audit. An attorney may count towards her/his New York CLE requirement credit earned through the Approved Jurisdiction policy without notifying the CLE Board.

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Knowledge Congress is not yet an Accredited Distance Learning Provider in PA, neither the instructors nor any PA attendees will receive credit for the course.



 
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