FDA Guidance Documents on Social Media: Rules and Suggestions

Duration: 60 Minutes
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.
FDA Guidance on Social Media Marketing
Instructor: Mukesh Kumar
Product ID: 501038

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.

This webinar 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.

Why Should you Attend
The webinar 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.

Objectives of the Presentation
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 are:
  • 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
Who can Benefit
  • 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
$375
Recorded Session for one participant
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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