New Developments in the World of Section 230
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
WHAT IS, AND IS NOT, ADVERTISING? At the outset it is important to understand what is, and is not, considered to be advertising or an advertisement under U.S. law. Generally speaking, as applied to any product, be it beer,...more
Last week, Maine enacted an internet privacy law requiring broadband internet service providers (ISPs) to obtain a customer’s express, affirmative consent before using their personal information, including browsing history....more
Editor's Overview - This month’s newsletter features an article on the DOL’s recently published interim final rule that increases penalties for notice and disclosure violations, which generally became effective on...more
A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more
The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more
The Federal Circuit has decided to revisit the constitutionality of Section 2(a) of the Lanham Act in the case of In re Shiao Tam, 2015 U.S. App. LEXIS 6840 (Fed. Cir. Apr. 27, 2015). Section 2(a) of the Lanham act allows the...more