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Key Takeaways from FDA’s Draft Guidance on Communications Consistent with Labeling and Memorandum on Off-Label Communications
Key Takeaways from FDA’s Draft Guidance on Communications Consistent with Labeling and Memorandum on Off-Label Communications


 
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Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.

In January of 2017, the FDA released a 63 page memorandum on First Amendment considerations related to off-label communications, as well as a draft guidance entitled “Medical Product Communications that are Consistent with the FDA-Required Labeling”. This guidance comes on the heels of a lively two day meeting the FDA held in November to address stakeholder concerns and challenges on communications regarding off-label use of drugs and medical devices. While the draft guidance provides some clarity around permissible on-label communications, uncertainty remains for off-label communications and the turn of the new administration may delay FDA providing any further certainty.
  • Key takeaways and best practices for ensuring on-label marketing claims “consistent” with product labeling
  • Understanding FDA’s First Amendment
  • Insights from 6 enforcement letters FDA issued in December 2016
  • Audience polling on marketing and communication examples based on FDA’s current recommendations



Speaker:
Julie Tibbets
Partner
Alston & Bird LLP


Participants that will find this webinar most beneficial will be those involved in pharmaceutical and medical device companies. Job titles of attendees that will be most applicable for this session will be:

  • Compliance
  • Advertising & Promotion
  • Sales & Marketing Compliance
  • Regulatory Affairs

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