Tag Archives: advertising and promotion

2016 Year in Review: FDA Advertising & Promotion Enforcement Activity

Warning and untitled letters issued to manufacturers of medical products offer unique insight into FDA’s enforcement practices. To help identify themes and trends in the agency’s recent enforcement activity, Covington & Burling has reviewed all warning and untitled letters related to advertising and promotional materials issued in 2016 and tabulated the most frequently cited allegations. … Continue Reading

FDA Advertising and Promotion Enforcement Activities in March 2014

The Office of Compliance (OC) in the FDA’s Center for Devices and Radiological Health issued a warning letter to NeoMedix Corporation regarding the Trabectome High Frequency Generator/LP (Trabectome) on February 26, 2014. The warning letter included allegations that Neomedix’s website made claims about Trabectome that represented a “major change or modification” of the device’s intended … Continue Reading

Summary of FDA Advertising and Promotion Enforcement Activities in July and August 2013

On July 31, the Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) issued a warning letter to Wonjin Mulsan Co., Ltd. regarding its POWER-Q1000 Compressible Limb Therapy System (“POWER-Q1000”). Based on an inspection of the Wonjin Mulsan Co., Ltd.’s facility in South Korea, the letter included several allegations related to … Continue Reading

Summary of FDA Advertising and Promotion Enforcement Activities in May 2013

Covington & Burling LLP issues monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, medical devices, and biologics.  In May 2013, FDA’s Office of Prescription Drug Promotion (OPDP) posted five such letters, and the Office of Compliance and Biologics Quality (OCBQ) in FDA’s … Continue Reading
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