On January 13, 2014, FDA issued a draft guidance document entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”  This draft guidance addresses the procedural topic of submitting Forms FDA 2253 and 2301 when firms use social media such as blogs, microblogs, social networking sites, online communities, and podcasts to promote human and animal drugs. Although the draft guidance focuses on the submission of postmarketing reports for drugs and biologics, it addresses the broader principle of when firms are responsible for various types of social media communications.  It remains to be seen whether the principles discussed in the draft guidance will be adopted by the Center for Devices and Radiological Health (CDRH) and applied to device promotion.  A summary of the guidance, and a discussion of the issues it raises, can be found in our recent e-alert, here.