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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
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
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
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
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
One author's view on how to determine the answer that may surprise you....more
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
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
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
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
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
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more
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
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
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
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
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
State and federal courts reject efforts to categorize salmonella as a "communicable disease."
While the quality of the United States' food supply continues to be exceptionally reliable, problems do occasionally arise....more
Yesterday the California Department of Toxic Substances Control (DTSC) convened a Green Ribbon Science Panel (GRSP) to continue work on the state's Green Chemistry initiative.
Readers may recall from previous posts that...more
In an effort to protect children (and, to a lesser extent, adults) from toxic exposure, California has banned the use of the controversial chemical Bisphenol A (BPA) in baby bottles and sippy cups, and has eliminated certain...more
This week the FDA released a plan for fostering innovative science. It is entitled the “Strategic Plan for Regulatory Science,” and it focuses on the agency’s goal to enhance the processes for developing and evaluating new...more
On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”1 Once finalized, the document will...more
You may never need to fill out a form when you visit a doctor's office. Instead of having a different medical record number at each hospital or doctor's office, patients can have their entire medical history accessible online...more
In a highly anticipated new development, California’s Department of Toxic Substances Control (“DTSC”) submitted its Green Chemistry Proposed Regulation for Safer Consumer Products to the state Office of Administrative Law...more
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