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Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Late last month, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued its fourth Untitled Letter of the year to AbbVie, Inc. OPDP uses Untitled Letters to inform drug companies and...more
Plaintiff Says Splenda 100% Natural Ad Claims Leave a Bitter Taste - A class action lawsuit accuses the makers of Splenda Naturals Stevia, a sugar alternative, of misleading consumers with the claim that the product is...more
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more