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Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
The Federal Trade Commission is taking a hard look at marketing and advertising statements, making sure they are precise and accurate. Here are some key takeaways from recent enforcements:...more
As previously blogged about here, following notices of proposed rulemaking in 2022 and 2023, on August 22, 2024 the Federal Trade Commission finalized a rule that will impose monetary civil penalties false and misleading...more
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
On July 13, 2023, The Washington Post broke the news that the Federal Trade Commission (FTC) had issued a Civil Investigative Demand (CID) — a sort of a pre-litigation subpoena as part of what is supposed to be a nonpublic...more
On April 14, 2023, the U.S. Supreme Court afforded defendants the ability to directly challenge the structural constitutionality and existence of the Federal Trade Commission (and the Securities and Exchange Commission) in...more
In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices. A summary of the noteworthy...more
It has been almost 40 years since Bruce Springsteen first famously celebrated being American-made with his hit "Born in the USA." From an advertising industry perspective, this song's lasting popularity is no surprise;...more
The Australian Competition and Consumer Commission (ACCC) continues to focus on misleading and deceptive advertising and communication strategies adopted by businesses selling products and services as an enforcement priority....more