Many years have passed since FDA began attempting to enunciate a regulatory approach to digital and social media – beginning in 2009 and still presumably on-going. In June the most substantive guidance yet was released by the agency addressing two critical areas that were outstanding – the correction of misinformation by third parties about prescription products and medical devices, and addressing the challenges of including risk information in product specific communications where there are character limitations.
With the passage of so much time, however, and since digital and social media are expansive topics, it is somewhat difficult to keep track of everything that has occurred. To help in that regard, I’ve put together a tab on the Eye on FDA blog site that contains the following:
- Compilation of all relevant guidances
- Links to relevant Warning and Untitled Letters
- A link to my White Paper on the Regulation of Digital Media by FDA which compares enforcement patterns by OPDP for digital and non-digital communications vehicles;
- Links to relevant pages on the FDA site that pertain to the regulation of digital media
If there are any other resources on the FDA site that I have overlooked, by all means I welcome suggestions. In the meantime, I hope you will find this a useful resource.
Also, if you haven’t done so yet, there is still time to sign up for my free Webinar being given this Thursday, July 17 at 12 Noon E.S.T. – “In More than 140 Characters – FDA’s Social Media Guidance: Past, Present and Future” where I will be taking a comprehensive look at FDA’s approach to regulating social media by examining each of the five questions raised in the November 2009 hearing held on the topic.