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Two FDA Guidelines Help Life Sciences Companies Solve Social Media Conundrums - Social media presents new challenges for life sciences companies. Companies that post about their products on space-constrained social...more

PSC to Discuss Draft Phthalates Rule at December 5th Meeting

On December 5, 2014 the U.S. Consumer Product Safety Commission (CPSC) will be briefed by staff on a recommendation to issue a proposed rule to permanently prohibit five phthalates – DINP, DIBP, DPENP, DHEXP, DCHP – from...more

CPSC Focusing on Three Areas for Reduction of CPSIA Testing Burdens

At their April Senate confirmation hearing, both incoming CPSC Chairman Elliot Kaye and Commissioner Joe Mohorovic pledged to Senator John Thune (R-SD) to submit plans for reducing third party testing burdens within 60 days...more

Enforcement Priorities and Trends in Children's and Minors' Advertising and Privacy

BakerHostetler's Alan Friel recently interviewed FTC staff lawyer Kandi Parsons and Assistant New Jersey Attorney General Elliot Sibers at the opening session of the Children's Advertising Review Unit ("CARU") of the...more

Advertising Law - November 2014

Lawmakers: Time to Discuss the Internet of Things: What are the privacy, security, and consumer protection implications of the burgeoning Internet of Things? A group of senators has called for a hearing to...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

Get Ready Now for the Upcoming Proposition 65 Warning Requirements for DINP and Other Chemicals

With the 2014 holiday season fast approaching, businesses should not lose sight of what the Proposition 65 “bounty hunter” plaintiffs’ lawyers are eagerly awaiting. And that’s the opportunity to send out 60-Day Notice letters...more

Advertising Law - September 2014 #2

Use of Flawed Study Results in $3.5M Settlement with FTC - For relying upon the results of a flawed study to make what the Federal Trade Commission characterized as “baseless” and “hopelessly flawed” weight-loss claims...more

‘Chemical (Over)reaction’?: States Push for Tighter Regulation of Consumer Products

The chemical wars are in full swing. And for consumer products and chemicals manufacturers, victory on the regulatory front is by no means a foregone conclusion. Progressive legislators in states such as California,...more

Alabama Supreme Court Reaffirms That Plaintiffs Who Use Generic Drugs Can Recover From Brand-Name Manufacturers

On August 15, 2014, the Alabama Supreme Court held for the second time in Wyeth v. Weeks, No. 1101397 (Ala. 2014) that a plaintiff who took only the generic version of the heartburn medication Reglan could nevertheless...more

Federal Judge Trims Diet Supplement Maker’s Earnings by $40M and Orders Recall of Banned Labeling

On May 14, a Georgia federal court dished out severe contempt sanctions against Hi-Tech Pharmaceuticals, its president and two others for violating a 2008 court order relating to the advertising and labeling of Hi-Tech’s...more

Should Have Stayed on The Farm(ville): Class Action Plaintiffs' ECPA Claims Put Out to Pasture

Ah, to be a class action plaintiff these days. One day you’re up, plowing through the Northern District of California on expansive theories of injury, the next you’re down, upended like a top-heavy apple cart by a failure to...more

Who Is at Fault When a Driverless Car Is in an Accident?

One author's view on how to determine the answer that may surprise you....more

Unauthorized Children’s In-App Purchases Round Two: Google Faces Class Action

Just two months after Apple’s settlement with the FTC over lax parental controls over children’s in-app purchases, Google takes the spotlight with claims of unauthorized children’s in-app purchases in the Google Play Store!...more

Recent Trends in Class Action and Aggregate Litigation in the Life Sciences Industry

Introduction - For the last several years, the life sciences industry has been fertile ground for class action and aggregate litigation. Developments in this area have driven several trends, including state consumer...more

Consumer Protection Laws And Prescription Meds: A Poor Fit

Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury,...more

After Recalls, Pharmacies Wonder How Well They REALLY Know Their Subcontractors

Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

“Food Fraud Database”: a New Tool to Protect Against Tainted Ingredients

Last week, the U.S. Pharmacopeial Convention (“USP”), a scientific nonprofit that sets standards for food ingredients, medicines and dietary supplements enforceable by the Food and Drug Administration, released an updated...more

FDA Announces Publication of Two Proposed Rules Implementing the Food Safety Modernization Act

On Friday, January 4, 2013, FDA announced the pre-publication of two long-awaited proposed rules implementing parts of the Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011....more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

FDA Unveils New System to Track Medical Devices

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Unveils New System to Track Medical Devices

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Announces 100k Genome Project

The Food and Drug Administration(FDA) and the Centers for Disease Control (CDC) are collaborating with the University of California Davis and Agilent Technologies, a chemical analysis/engineering company from Santa Clara,...more

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