Saurabh Anand

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FDA Issues Untitled Letter Focused On Promotional Claims On Facebook

FDA has previously included claims made on Facebook or other social media platforms along with broader allegations of misbranding using a variety of sources in its enforcement letters . . . [b]y contrast, the present untitled letter focuses solely on a single statement on a Facebook page, and does not take issue with any statements outside the Facebook page.… Continue Reading

FDA Issues Draft Guidance on Postmarketing Requirements for Promotion on Social Media

On January 13, 2014, FDA issued a draft guidance document entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs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 This draft guidance addresses the procedural topic of submitting Forms FDA 2253 and 2301 when firms use social media such as blogs, microblogs, social networking sites, … Continue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