Warning Letters

News & Analysis as of

Taking Notice of Notice Letters [Video]

Companies of all sizes find it increasingly difficult to avoid claims of patent infringement being raised against them. Often these claims come in the form of a notice letter, but what are notice letters, and more...more

FDA Releases Warning Letters to Providers Concerning Clinical Trial Supervision

The FDA recently released three warning letters that it previously issued to two health care providers relating to prescription drug and medical device clinical trials. The letters, sent in late 2013 and early 2014, detail...more

$1.2 Billion Medicaid Fraud Penalty Award Reversed and Claim Dismissed in Arkansas Appeal

In another decision narrowing the scope of state Medicaid fraud statutes, on March 20, 2014, the Supreme Court of Arkansas, in Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State of Arkansas, No. CV-12-1058, unanimously...more

2013 Year in Review: CDRH Promotion and Marketing Enforcement Letters

In 2013, FDA’s Center for Devices and Radiological Health (CDRH) made publicly available on its website a total of 22 promotion and marketing-related enforcement letters to device manufacturers. Of the 22 enforcement letters,...more

Advertising News & Analysis - January 23, 2014

In this issue: - Former BCP Director Discusses how FTC Picked its Fights - Court Pierces the Veil on Anonymous Online Reviews - FTC Finds Green Diaper Claims Don’t Hold Water - A Warning Letter is...more

The Warning Letter Is Only the Start

So you’ve had a bad day — FDA has told you to stop marketing your product. The good news, things can only get better, right? Maybe not if a class action follows hot on the heels of FDA’s order. This, in brief, is the...more

D’oh! Employment Law According to Homer Simpson

We have all lived in a highly regulated, pro-employee environment for years. Moreover, there is no hiding it; employers are bombarded by news about the hazards of having employees which illustrate the various pitfalls, often...more

FTC Sends FCRA Warning to Providers of Rental Histories

The Federal Trade Commission continues to keep Fair Credit Reporting Act (FCRA) enforcement at the forefront of its activities, as shown by its recent warnings to operators of six websites that provide information about...more

Advertising Law -- Mar 08, 2013

In This Issue: Marc Roth to Lead Social Media and Mobile Marketing Discussion at PACE Association Convention; UK Court Finds Google Could be Liable for Blog Comments; TCPA Plaintiffs Victorious in Illinois, New Jersey;...more

2012 Year in Review: FDA OPDP Warning Letters and Untitled Letters

In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters,...more

Class Action Lawsuits Attack Yogurt Products for Nonconformance with Standards of Identity

Over the past eight months, numerous class action lawsuits have been filed by consumers against yogurt manufacturers regarding the use of milk protein concentrate (“MPC”) as an ingredient in yogurt products. Generally, the...more

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