Tag: untitled letter

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 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 Holds First OPDP Enforcement Webinar of 2014

Today the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) held its first enforcement webinar of 2014, addressing enforcement actions taken in Q3 and Q4 of 2013.  These enforcement actions included: Q3 2013:  Brovana, Dalfampridine (Ampyra), Naftin, Zevalin Q4 2013:  Aranesp, Benicar, Cedax, Dantrolene Sodium, Diclegis, […]

Regulator Panel at FDLI’s Advertising & Promotion Conference

The Food and Drug Law Institute (FDLI) is hosting its annual Advertising & Promotion Conference for the Pharmaceutical, Medical Device, Biologic & Veterinary Medicine Industries this week in Washington DC. The conference kicked off this morning with the highly anticipated Food and Drug Administration (FDA) regulator panel that included Thomas […]