FDA Social Media Guidance Removes Some Barriers

This week, the FDA issued draft social media guidance specifically focused on requirements, responsibility and process for postmarketing submission for approved drugs and biologics. While the long official title is “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” the document covers two primary areas: Considerations to determine when interactive media (Facebook, Twitter, blogs, forums, etc.) are subject to the FDA’s postmarketing submission requirements How firms can maintain regulatory compliance given the unique features...