On March 12, FDA’s Office of Prescription Drug Promotion (“OPDP”) posted an untitled letter on its webpage alleging that Institut Biochimique SA’s (“IBSA”) Facebook page for the drug Tirosint® misbranded the drug.  The untitled letter is particularly noteworthy for its focus on one statement on a firm’s Facebook page.
Continue Reading FDA Issues Untitled Letter Focused On Promotional Claims On Facebook

On January 13, 2014, FDA issued a draft guidance document entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs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  This draft guidance addresses the procedural topic of submitting Forms FDA 2253 and 2301 when firms use social media such as blogs, microblogs, social