This post was also written by Erin Janssen. With only days to spare in 2011, and after two years of anticipation, FDA’s Internet and social media policy is finally starting to emerge. On December 27, 2011, FDA announced the availability of draft guidance entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” The guidance describes FDA’s current thinking about how manufacturers and distributors of prescription drugs and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use related to their FDA approved or cleared products. The guidance updates and clarifies FDA’s policies on such unsolicited requests for information, and is the agency’s first foray into guiding the industry on how it may use social media and the Internet to engage with customers. This is a first step in what has been (and will continue to be) a long process within the Agency to establish a framework for regulating the Internet and social media, provide guidance to the industry, and find a way to adapt to emerging technologies. FDA is expected to issue multiple guidance documents in 2012 on the Internet and social media. Comments on the draft guidance are due March 29, 2012.