Overview:
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
If the information can reach a consumer, FDA cares, even if you did not publish the information. Firms need to watch for promotional trespassers. Websites, chat rooms, op-ed articles, or even your own postings on social media can cause your product to be misbranded, i.e., illegal.
One big issue is how you patrol and control what someone else is saying about your product in a public forum. Once the off-label information is out there, what is the scope of your responsibility?
Why you should Attend:
- What is considered "off-label"
- Using social media website "likes" and links
- Direct to Consumer promotion pitfalls
- Fair and balanced information
Areas Covered in the Session:
- Understand how social media is labeling
- Learn how third parties place you in jeopardy
- Understand FDA's concern about "fair and balanced" information
- Ways to define your social media responsibilities
- Apply FDA Guidance Documents on DTC / social media labeling
Who Will Benefit:
- Regulatory Affairs Directors
- Marketing Directors
- Sales Managers
- Website Managers
- Importers
- Clinical Establishments/Institutions
- Clinical Sponsors
- Quality Assurance Managers