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Results: 1-10 of 17,904

PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine
  • Reed Smith LLP
  • USA
  • July 25 2017

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory


Janssen Biologic Tremfya Secures FDA Approval Following Use of Priority Review Voucher
  • Knobbe Martens
  • USA
  • July 25 2017

On July 13, 2017, the U.S. Food and Drug Administration approved Tremfya (guselkumab), a biologic manufactured by Janssen Biotech, for the treatment


Ohio Board of Pharmacy Passes Resolution Requiring Changes to Request Forms for Drug Samples and Complimentary Supplies
  • Loeb & Loeb LLP
  • USA
  • July 25 2017

The Ohio Board of Pharmacy (BoP) notified manufacturers and distributors July 14, 2017, of a resolution creating a modified process for verifying the


Lawsuit: Cannabis Criminalization is Unconstitutional
  • Duane Morris LLP
  • USA
  • July 25 2017

Former NFL star Marvin Washington and others yesterday filed a lawsuit in New York against the US Government and Attorney General Jeff Sessions. The


Product liability: Emerging risks pose challenges for insurers and defendants
  • Clyde & Co LLP
  • USA
  • July 25 2017

Product liability exposure is garnering a growing amount of attention from defendant companies and their insurers for a plethora of reasons. Among


House Panel Approves Sweeping Proposal On Autonomous Vehicles, Putting Innovation Above Regulation
  • Buchalter
  • USA
  • July 24 2017

On July 19, 2017, a U.S. House panel took a significant step to clear the way for autonomous vehicles by approving a proposal allowing automakers to


Food & Beverage Litigation Update: Issue 641
  • Shook Hardy & Bacon LLP
  • USA
  • July 24 2017

A bipartisan group of U.S. senators has introduced a bill that would require labeling of genetically engineered (GE) salmon and independent


Food, Drug and Device Law Alert - FDA Publishes List of Class II Devices to Be Exempted From 510(k) Process
  • Barnes & Thornburg LLP
  • USA
  • July 24 2017

The 21st Century Cures Act required the Food and Drug Administration (FDA) to publish a notice in the Federal Register - within 120 days for Class I


Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees
  • Knobbe Martens
  • USA
  • July 24 2017

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a


Food and Beverage News and Trends 24 July 2017
  • DLA Piper LLP
  • USA
  • July 24 2017

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. What