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Results:1-10 of 820

Trying To Make A Food Labeling Claim Stick
  • Reed Smith LLP
  • USA
  • December 14 2018

Our last post talked about carbohydrate-rich Thanksgiving food. Today, we are talking about a putative class action on the labeling of certain diet


FDA De Novo Device Classification Process & Preemption
  • Reed Smith LLP
  • USA
  • December 10 2018

The FDA has recently released a proposed rule “to establish requirements for the medical device De Novo classification process” provided in 21 U.S.C


FDA Announces Its Plan for Encouraging Reliance on Newer Predicate Devices and Medical Device Performance Criteria
  • Reed Smith LLP
  • USA
  • December 7 2018

On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway” by encouraging


The Demise of Drug Design Litigation: Death by Federal Preemption
  • Reed Smith LLP
  • USA
  • December 3 2018

That is the intriguing title of the latest law review article written by the “Rabbi of Torts,” Prof. Aaron Twerski (we’re not making this up, Prof


FDA Publishes Draft Updated Guidance on Medical Device Cybersecurity
  • Reed Smith LLP
  • USA
  • November 16 2018

We celebrated National Cybersecurity Awareness Month a few weeks ago by bringing you the FDA’s newly published Medical Device Cybersecurity Regional


Final Curtain for Plaintiffs’ Experts in the Mirena IIH MDL
  • Reed Smith LLP
  • USA
  • November 9 2018

Kudos to the multi-firm defense counsel team that brought home the decision on which we report today, a victory that may well end up on our “best”


The Diagnostic Artificial Intelligence Speedbump Nobody’s Mentioning
  • Reed Smith LLP
  • USA
  • November 8 2018

The 21st Century Cures Act is noteworthy as the first legislative attempt at regulating artificial intelligence (“AI”) in the medical field. The Act


FDA Overhauls Premarket Cybersecurity Guidance for Device Makers
  • Reed Smith LLP
  • USA
  • November 6 2018

On October 18, 2018, the Food and Drug Administration (“FDA”) released a draft update to its guidance on the “Content of Premarket Submissions for


Just Fruit? Kind Faces Yet Another Class Action Lawsuit
  • Reed Smith LLP
  • USA
  • November 6 2018

Last month, a class-action lawsuit was filed in federal court alleging that Kind, LLC (“Kind”) deceptively advertises certain Kind bars and fruit


Federal government takes steps toward ubiquity of cannabis drugs
  • Reed Smith LLP
  • USA
  • November 1 2018

The federal government finally seems ready to acknowledge the potential advantages of medicinal CBD and marijuana-derived medication. The Food and