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Results: 1-10 of 3,816

After 19 Years, FDA Issues Final Rule on GRAS Notices
  • Barnes & Thornburg LLP
  • USA
  • August 22 2016

The Food and Drug Administration (FDA) recently issued a final rule that amends and clarifies the criteria for when the use of a substance in food


New FDA Draft Guidance Helps Define the Scope of 510(k) Medical Device Preemption
  • Reed Smith LLP
  • USA
  • August 22 2016

Earlier this month the FDA issued a draft guidance entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device." It's long, and


Guest Post - Through the Dictionary, and What One Court Found There: Adventures in the BAAA
  • Reed Smith LLP
  • USA
  • August 19 2016

It's August and several your valiant bloggers are on vacation, so the skeleton crew manning the fort is even more grateful for reinforcements than


The State AG Report Weekly Update August 18, 2016
  • Cozen O'Connor
  • USA
  • August 18 2016

Hillary Clinton’s campaign announced that former Colorado AG Ken Salazar will chair Clinton’s White House transition team. Salazar will chair the


Guest Post Marion Even with a Road Map, Only One Dubious Claim Navigates Preemption
  • Reed Smith LLP
  • USA
  • August 17 2016

Here's another guest post, this time from Reed Smith's Elizabeth Graham Minerd. This post concerns PMA preemption, and a second opinion largely


FDA Issues Final Rule on Food Ingredients that May Be Generally Recognized as Safe (GRAS)
  • McDermott Will & Emery
  • USA
  • August 17 2016

The US Food and Drug Administration (FDA) has issued this final rule detailing the criteria for concluding that the use of a substance in human or


Brand Defendants Thwart Another Innovator Liability Claim
  • Dechert LLP
  • USA
  • August 16 2016

Looking back at our posts on innovator liability, it’s becoming more and more difficult to title them. According to the DDL blog, innovator liability


Responsible Corporate Officers’ Jail Sentences Upheld in Selling Contaminated Eggs
  • Volkov Law Group
  • USA
  • August 15 2016

In an important decision, on July 6, 2016, the Eighth Circuit Court of Appeals affirmed the prison sentences imposed on Jack DeCoster, and his son


A Tour of NAD Takes on Claims
  • Kelley Drye & Warren LLP
  • USA
  • August 15 2016

The NAD recently reviewed claims for an omega-3 supplement. See Prevention Pharmaceuticals, Inc., NAD Case No. 5966 (July 2016). The NAD found that


Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard - and More
  • Reed Smith LLP
  • USA
  • August 15 2016

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v