Off-Label Drug Promotion
FDA’s Recent Enforcement in the Product Promotional Arena

Monday, Jan. 30, 2017 · 1:30 p.m. - 2:30 p.m. EST

Early Bird Savings:
Register by Jan. 16 and Save $100

The FDA allows manufacturers to engage in off-label communications under certain circumstances including: responses to unsolicited requests — through sponsorship of continuing medical education events where off-label uses are discussed — peer-reviewed journal articles — medical texts — and clinical practice guidelines containing off-label information.

Recently, the FDA’s authority to restrict off-label communications has been successfully challenged in a series of court decisions suggesting that companies may distribute truthful — non-misleading information — about off-label uses of their products without violating the FDCA.

On Nov. 9-10, 2016 the FDA held a public hearing on manufactures ability to communicate information about unapproved uses of medical products that have at least one approved or cleared indication — or “off-label communications.”

Join legal expert Alan Minsk — of Arnall Golden Gregory — on Jan. 30 when he’ll discuss the FDA’s latest rules on what speech is and is not protected.

In this 1-hour webinar you will learn about:

  • FDA’s enforcement against pre-approval promotion
  • The PhRMA/BIO principles on sharing truthful and non-misleading information
  • FDA's recent public hearing on off-label communications
  • Non-FDA-related issues to consider with off-label promotion
  • A look ahead to where might we be headed

Register today and learn about how you can promote off-label uses of your drug while remaining compliant with FDA regulations.

Who Will Benefit

  • Compliance officers
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Sales/marketing personnel
  • Strategic planning and business development staff

Webinar plus Audio CD/Transcript
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Webinar only
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$287
$187

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24/7 Encore plus CD/Transcript
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$487
$387

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24/7 Encore Presentation
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$287
$187

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Audio CD/Transcript
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$287
$187

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Meet Your Presenter

Alan G. Minsk

Partner and Leader of the Food and Drug Practice Team
Arnall Golden Gregory

Alan G. Minsk is a partner and leader of the Food and Drug Practice Team at Arnall Golden Gregory. Mr. Minsk focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, food (including dietary supplements and medical foods) companies, on all legal and regulatory matters relating to the FDA.

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.

Phone (703) 538-7600 | Fax (703) 538-7676 | Toll free (888) 838-5578 | Email customerservice@fdanews.com

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