Webinars >>FDA Guidance
FDA Guidance Documents on Social Media: Rules and Suggestions

FDA is mandated by law to regulate marketing of FDA-regulated products via social media. Recently FDA has published two guidance documents specifically addressing its recommendations for best practices for social media marketing and several more are believed to be in the works. FDA regulated products need to follow strict information control; which is hard if not impossible with social media portals. More importantly, FDA guidance documents so far address only prescription products, while the non-prescription drugs, dietary supplements, cosmetics, and other over-the-counter products are untouched, unacceptable marketing of which is equally prone to FDA action seeing the several of warning letters issued to those products.  Social media marketing concerns all kinds of products and there exist signification confusion about FDA’s rules and expectations to avoid penalties.
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This seminar will discuss the latest FDA guidance documents, and letters to manufacturers to provide an overview of the current rules. The speaker will present a synopsis of the FDA guidance with his insight based on thorough review of the history of these guidance documents and the genesis of FDA’s rationale behind these guidance documents. This presentation will present ways to use social media that are compliant with FDA regulations. Practical regulatory strategies will be suggested to ensure compliance and balanced social media activity.
Areas Covered in the Session:
  • Current FDA guidance documents for social media
  • Social media guidance in the works at FDA and their potential application
  • FDA’s expectations for social media best practices
  • Training of personnel on FDA’s social media guidance
  • Recent trends in FDA enforcement actions involving social media.
  • Recent discussions about social media in marketing of FDA-regulated products.
Why should you attend:
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The seminar will summarize FDA’s guidance documents, recent warning letters, and latest news worthy events that highlight how FDA looks are social media use by industry. Common issues, misconceptions, perceptions, and possible solutions will be discussed. In a social media rich environment, manufacturers cannot avoid information dissemination via social media, hence it is prudent to familiarize with the current processes and plan for developments expected in the near future.
Who will benefit: 

The following individuals or disciplines will benefit from attending this Webinar:
  • Compliance Management
  • Regulatory Vice Presidents, Directors and Managers
  • Attorneys – In-house or Outside Counsel
  • Senior executives of pharmaceutical and device firms
  • Marketing Management
  • Sales Vice presidents, Directors and Managers
  • Clinical Management
Date: February 23, 2016
Time: 1 PM ET        
​Duration: 60 Minutes

Speaker
Mukesh Kumar, PhD, RAC, VP (Regulatory Affairs and Quality Assurance), Amarex Clinical Research, USA
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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com