Polsinelli Podcast - FDA Proposed Changes to Food Labels and What it May Mean for Manufacturers
Manufacturers, Importers and Retailers Must Take Action Following DTSC Reveal of Priority Products
Doing Business in California, Proposition 65, the California Green Chemical Initiative and the Rigid Plastic Packaging Regulations
Polsinelli Podcast - Food Safety Modernization Act
Bill on Bankruptcy: Delaware Garners Almost All Big Chapter 11s
Bill on Bankruptcy: Listening in the Dark at the NCBJ
Dean: Law Schools Use Merit Scholarships To Boost Rankings
Dean: Law Firms 'Support' NYLS's 2 Year Degree Program
Bill on Bankruptcy: LightSquared, the Battle among Hedge Funds
Bill on Bankruptcy: Appeals Court Changes the Law on Fraud
Bill on Bankruptcy: Make-Whole Premiums, Lehman, ResCap
Rice: Banking Lobby Won't Let New Glass-Steagall Bill Pass
Bar President: 3Ls Should Get Paid for Internships
Bill on Bankruptcy: Lawyers Must Disclose What Clients Pay
NALP: 18-Year Low for Law Grad Employment
Is Edward Snowden a Whistleblower?
Unique Privacy Concerns for Mobile Apps
Instapundit: America's IP Laws Need to be "Pruned Back"
Bill on Bankruptcy: Trustees Sleep Easy after High Court Ruling
Could This Law School Ranking Unseat US News?
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The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more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
The fluoridation materials used to fluoridated drinking water are not tested or approved by any federal or state agency. Fluoridation materials are added to drinking water for health reasons - to prevent tooth decay, and so...more
The silicofluorides typically used to fluoridate water contain lead, leach lead from pipes and solder, and facilitate lead uptake by the human body. The Safe Drinking Water Act requires disclosure to the public regarding lead...more
Class Action Complaint accusing Apple and AT&T of knowingly distributing a phone with a malfunctioning antenna.
Apple (maker of iPhone 4)and AT&T are accused of numerous infractions. The Complaint asserts causes of...more
On April 9, 2009, the Food and Drug Administration (FDA, or the Agency) issued an order that requires manufacturers of 25 high risk Class III medical devices, which were marketed before 1976 but have not yet undergone the...more
IN THIS ISSUE:
*Federal ban on pthalates won't apply to goods already in warehouses or on store shelves
*Software tracks new REACH list of substances
*Green chemical companies work toward sustainable solutions
IN THIS ISSUE:
*Wal-Mart spent $2.2 million lobbying consumer product safety legislation
*California seeking input on its green chemistry initiative
*Canadian government begins process to ban everyday...more
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