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FDA released a 63-page memorandum on First Amendment considerations related to off-label communications, as well as a draft guidance entitled “Medical Product Communications That Are Consistent with the FDA-Required Labeling.”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 While the draft guidance provides some clarity around permissible on-label communications, uncertainty remains for off-label communications, and the turn of the new Administration may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
For more information, click here.