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Results: 1-10 of 11,363

FDA Provides Guidance on 3D-Printed Medical Device Products
  • Knobbe Martens
  • USA
  • December 8 2017

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on


Third Circuit Splits with the Seventh Over Standing To Sue For Alleged Inefficient Design of Eye Drop Dispenser
  • Proskauer Rose LLP
  • USA
  • December 6 2017

In a surprising decision and split with the Seventh Circuit, the Third Circuit recently held that plaintiffs have standing to sue for unfair trade


Shopping For Standard Food Date Labels
  • Keller and Heckman LLP
  • USA
  • December 6 2017

Your milk says “use by”. Your cheese says “best by”. Those pastries? “Enjoy before.” Supermarket shelves are overflowing with food and beverage


It’s Only “Natural:” Avoiding the Risk of Consumer Lawsuits Over Food Labels
  • Verrill Dana LLP
  • USA
  • December 6 2017

Americans are increasingly sensitive to the ingredients that go into the food that we eat. Recently, Congress passed a law requiring manufacturers to


Cyber Risk News & Trends - December 2017
  • Buchanan Ingersoll & Rooney PC
  • USA
  • December 5 2017

Internet data breaches threaten the usernames and passwords of billions of people, but bad actors find phishing is the most effective way to hijack


Litigation vs. Licensing: Manufacturers of the Two Most Recently Approved Biosimilars Take Different Approaches to Reference Drug Patents
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • December 5 2017

The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb), which is


Washington Healthcare Update - Dec 4, 2017
  • McGuireWoods LLP
  • USA
  • December 4 2017

Testifying before the House Energy and Commerce Committee on implementation of the 21st Century Cures Act on Nov. 30, FDA Commissioner Scott Gottlieb


Menu Labeling Update: Plans On-Track for Implementation in May 2018
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • December 4 2017

On November 7, 2017, the U.S. Food and Drug Administration (FDA or the Agency) released the much-anticipated draft supplemental guidance, "Menu


New FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application
  • Tarter Krinsky & Drogin LLP
  • USA
  • December 4 2017

The U.S. Food and Drug Administration (FDA) recently published a draft guidance summarizing the differences between abbreviated new drug applications


A Practical Approach for Resolving the Pediatric Oncology Drug Labeling Crisis
  • Buchanan Ingersoll & Rooney PC
  • USA
  • December 1 2017

An undisputed crisis exists due to the absence of adequate labeling for pediatric oncology drug products. Almost all drugs used to treat pediatric