Webinar March 31, 2017

Key Takeaways from FDA’s Draft Guidance on Communications Consistent with Labeling and Memorandum on Off-Label Communications

Event Detail
March 31, 2017

Julie Tibbets was the featured speaker for this webinar program hosted by Q1 Productions. In January 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FDA released a 63-page memorandum on First Amendment considerations related to off-label communications, as well as a draft guidance entitled “Medical Product Communications That Are Consistent with the FDA-Required Labeling.”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 came on the heels of a lively two-day meeting the FDA held in November 2016 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 While the draft guidance provides some clarity around permissible on-label communications, uncertainty remains for off-label communications, and the turn of the new Administration may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 the FDA providing any further certainty.

  • Key takeaways and best practices for ensuring on-label marketing claims “consistent” with product labeling
  • Understanding the FDA’s First Amendment
  • Insights from six enforcement letters the FDA issued in December 2016
  • Audience polling on marketing and communication examples based on the FDA’s current recommendations

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Nicholas Clarke
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Phone: 212.210.1222

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