It is not a surprise that social media is one of the best marketing techniques if you want to get the word out about anything or mint profits. However, if you want to market specific medicines, biologics, medical devices and diagnostic kits you will have to follow the rules prescribed by FDA and get it approved by it before you distribute the information to consumers. This is a challenge with social media outlets where information may quickly get out of hand and may violate the FDA regulations – resulting in possible penalties on manufacturers.
Four guidance documents was recently released by FDA that described it to be best practices for use of Twitter-like services, published material, use of web-sites and other public disclosures for sharing marketing and off-label information, and even how to address misinformation at non-company controlled information outlets. In addition, FDA issued several Warning Letters to manufacturers indicating the rules for using social media in the last few years.
There is significant confusion among FDA regulated companies on how to use social media for marketing effectively and still be compliant with regulations. How can medical device, pharmaceutical and other FDA regulated industries use social media channels like Facebook, Twitter, YouTube, Pintrest, web-sites and other social media tools to get their message out in a way that is compliant with advertising and promotion regulations that are found in the Food Drug & Cosmetic Act? This presentation by Dr. Mukesh Kumar 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.
The conference will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. 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.
Points to be covered:
Who Should Attend
- Dr. David Lim
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
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