The Food and Drug Administration has once again postponed the release of its first draft guidance for social media. The federal agency was supposed to release the guidelines in late December, but stated at the time that it would delay the release of the first draft guidance until the first quarter of 2011. In a statement, the FDA said: “It is difficult to provide a timeframe for the issuance of our guidance’s due to the extensive work and review process, or ‘Good Guidance Practices’ (GGPs), which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic.” The most recent statement said that social media guidances will focus on six areas: responding to unsolicited requests, fulfilling regulatory requirements when using tools associated with space limitations, fulfilling post-marketing submission requirements, online communications for which manufacturers, packers, or distributors are accountable, and use of links on the Internet and correcting misinformation.
http://www.fda.gov/
