Below are links to resources related to FDA’s regulation of social and digital media. The page contains relevant guidances, key warning/untitled letters, and key web pages on the FDA site.
Guidances – Below are guidance documents listed in chronological order 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
- Fullfilling 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
- General Wellness: Policy for Low Risk Devices – January 2015
Warning/Untitled Letters – The following letters were issued either by OPDP or FDA regarding an aspect of digital social media which could be seen as providing insight into the agency’s thinking. It is not an exhaustive list of every letter issued that was connected to social or digital media:
- Non-OPDP Letter Regarding Use of Meta Tags – February 2015
- Sponsored Link Untitled Letter, OPDP – June 2014
- Facebook Share Widget, Untitled Letter, OPDP – July 2010
- Sponsored Link – 14 Letters, 45 Brands, OPDP – April 2009
White Paper – Regulatory Enforcement Digital Media
- Eye on FDA White Paper – FDA Communications Oversight in a Digital Era, published April 2013
FDA Web Resource Pages – The following are important resources provided by FDA on its site related to social/digital media:
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