The Future of Off-Label Marketing After the Caronia Decision 2013

Topics

• The fundamental principles that have guided off-label promotion in the past, including guidance documents from FDA on the dissemination off-label promotion or materials and responding to unsolicited requests for information on off-label uses, including on social media
• The implications of the Caronia decision and what it may mean for those that might be inclined to take advantage of its apparent endorsement of a First Amendment right to off-label promotion

Who should Attend

Personnel from FDA regulated companies involved in in the review and creation of marketing materials, including:

• Marketing
• Sales
• Legal
• Compliance
• Medical Affairs
• Regulatory Affairs
• Corporate Communications
• Clinical