FDA Guidance Social Media Digital Links

FDA Guidance Social Media & Digital Media

The FDA certainly does not “seem” to favor Social Media. However, the truth may be different. Find me on Linkedin to ask specific questions or to inquire about speaking engagements or training workshops on social media for Pharmaceuticals. I am not providing you with guidance myself in this post. Instead here is a compilation of links from the FDA in chronological order.

FDA Guidances Documents

Chronological list of FDA Guidance on social media or the use of digital media which address some aspect of digital or social media:

• Responding to Unsolicited Requests About Off-Label Information – December 2011
• Mobile Medical Apps – Guidance for Industry and FDA – September 2013
• Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media – January 2014
• Correcting Independent Third Party Misinformation About Prescription Drugs and Medical Devices – June 2014
• Platforms with Character Space Limitations – June 2014

Warning Letter and Untitled Letters

A collection of letters issued by the OPDP or FDA concerning digital media or social media. These are presented as a means of elucidating insights into the thinking of these organizations and are a sampling, not a comprehensive collection:

• Sponsored Link Untitled Letter, OPDP – June 2014
• Facebook Share Widget, Untitled Letter, OPDP – July 2010
• Sponsored Link – 14 Letters, 45 Brands, OPDP – April 2009

Resource Pages on the FDA’s website

Listing of important (but not comprehensive) resource pages found on the FDA’s website:

• Mobile Medical Apps
• Social Media
• Page on the November 2009 Public Hearing
• Slides from FDA Webinar on the June 2014 Social Media Guidance Documents
• Social Media Guidance Q&A