Event:
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The Caronia Court Decision and Off-Label Promotion
- Hosted By:
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ComplianceOnline
- Start:
- Wednesday - Feb 20, 2013 10:00 AM
- End Time:
- Wednesday - Feb 20, 2013 11:30 AM
- Location:
- Online
- This webinar will provide an introduction to FDA’s regulation of product labeling and promotion; and the Agency’s position with regards to off-label promotion and how the Court’s decision in the Caronia case might affect the off-label promotion of Rx drug products and medical devices.
Why Should You Attend:
This webinar is designed to provide attendees with an introduction to FDA’s regulation of product labels and labeling for prescription drugs and medical devices; and the off-label promotion of such products. The program will also offer attendees an overview of the risks associated with the off-label marketing and promotion of Rx drugs and medical devices including the prior issuing of Warning Letters, Untitled Letters and other enforcement activities by FDA’s Office of Prescription Drug Promotion or OPDP (formerly, the Division of Drug Marketing, Advertising and Communication or DDMAC).
Finally, the webinar will give participants an understanding of the Caronia decision, the legal framework behind it, its potential impact on FDA and Department of Justice enforcement policies, and how it might affect the off-label promotion of Rx drug products and medical devices.
- Website:
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Visit the website for detail info