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FDA Launches ‘Quik’ 510(k) Review Pilot Program
  • Knobbe Martens
  • USA
  • October 11 2018

The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to


Apple’s Latest Watch Receives FDA Approval For ECG Functionality
  • Knobbe Martens
  • USA
  • October 11 2018

Since its first release in 2015, the Apple Watch has continued to evolve and incorporate more health- and fitness-tracking capabilities. The latest


FDA Expresses Priorities for Clinical Trial Efficiency, Artificial Intelligence
  • Knobbe Martens
  • USA
  • October 11 2018

The FDA has announced new goals to help modernize its procedures and respond to new Technologies. In a blog post by FDA Commissioner Scott Gottlieb


First CBD Drug Receives FDA Approval
  • Knobbe Martens
  • USA
  • October 11 2018

The FDA recently announced its approval of GW Pharmaceutical’s Epidiolex drug, described as the first ever plant-derived cannabinoid medicine in the


FDA Approves First Generic Epinephrine Autoinjectors
  • Knobbe Martens
  • USA
  • September 30 2018

The United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors


FDA to Strengthen Cybersecurity Oversight
  • Knobbe Martens
  • USA
  • September 30 2018

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug


FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities
  • Knobbe Martens
  • USA, European Union
  • September 19 2018

On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that


FDA Grants Breakthrough Status to Dthera Sciences' Alzheimer's Therapeutic
  • Knobbe Martens
  • USA
  • September 4 2018

On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s


FDA Grants Breakthrough Status to Dthera Sciences’ Alzheimer’s Therapeutic
  • Knobbe Martens
  • USA
  • August 31 2018

On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s


BioSig Technologies Receives FDA 510(k) Clearance for Its Noninvasive Electrophysiology Information System
  • Knobbe Martens
  • USA
  • August 16 2018

The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System