Tag: social media

Kim Kardashian Drug Endorsement Results in FDA Warning Letter

The U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter this week to Duchesnay, Inc. related to celebrity Kim Kardashian’s social media posts on Instagram, Twitter and Facebook regarding the company’s drug, DICLEGIS. In the posts, Kardashian states that she is “partnering with Duchesnay […]

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors and packers that use social media and the internet to promote FDA-approved products.  The FDA has made the PowerPoint and webinar Q&As publicly available […]

FDA Releases Two Social Media Guidance Documents

The U.S. Food and Drug Administration (FDA) released today two highly anticipated draft guidance documents: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

FDA Enforcement of Pharmaceutical Websites Continues

The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently posted an untitled letter to Institut Biochimique SA (IBSA) and Akrimax Pharmaceuticals, LLC (Akrimax), the U.S. agent for Tirosint. The OPDP raised concerns regarding IBSA’s Facebook page for Tirosint because it failed to provide any risk information regarding its use, even though Tirosint is […]

FDA Releases New Draft Guidance for Postmarketing Submissions of Interactive Promotional Media

Draft guidance from the U.S. Food and Drug Administration (FDA) titled, “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics; Availability” was published today in the Federal Register.  The FDA defines “interactive promotional media” in the […]