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Results:1-10 of 582

FDA Generic Labeling Proposal - Six, Two, and Even, Over and Out
  • Reed Smith LLP
  • USA
  • December 17 2018

We opposed the FDA’s ill-advised 2013 proposal to revamp the process for changing generic drug labeling from the outset. We had legal objections -


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


A Couple of MDL Ideas from the Recent ACI DrugDevice Conference
  • Reed Smith LLP
  • USA
  • December 6 2018

Late last month Bexis attended the annual ACI Drug and Medical Device Conference in New York. In between helping to lead the discussion in the


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


Personal Jurisdiction Wins Cases
  • Reed Smith LLP
  • USA
  • November 29 2018

We’ve discussed personal jurisdiction a lot on the Blog lately, and not so lately, and for good reason. The Supreme Court’s reining in of both general


Pro-Plaintiff Hijacking Attempt Against New York Statute of Limitations
  • Reed Smith LLP
  • USA
  • November 26 2018

We maintain a number of “scorecards” on legal issues where we judge the defense advantage is sufficiently great that including all cases, even if


Another Nationwide Class Action Bites the Dust Under BMS
  • Reed Smith LLP
  • USA
  • November 20 2018

Bexis saw Bohemian Rhapsody last week and, as a result, is suffering from multiple Queen earworms. One is from the title song itself - “Caught in a


Sunset for Cy Pres, or Standing in Cyber-Privacy Litigation - Take Your Pick
  • Reed Smith LLP
  • USA
  • November 19 2018

We’ve always hated the concept of cy pres class action settlements. A cy pres distribution is an admission that, even without opposition, the


Biomaterials Access for the 21st Century
  • Reed Smith LLP
  • USA
  • November 12 2018

We’ve blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. 1601-06. In a nutshell, the BAAA provides suppliers of


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