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Results: 1-10 of 231

No Such Thing as Simple Food Labeling: Changes Ahead in 2018
  • Morgan Lewis
  • USA
  • April 9 2018

Significant statutory and regulatory changes are on the horizon this year in the world of food labeling as regulators and lawmakers introduce rules


FDA Delays eMDR System Adverse Event Codes Update
  • Morgan Lewis
  • USA
  • March 30 2018

The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5


Healthcare: What’s in the 2018 Omnibus Appropriations Law?
  • Morgan Lewis
  • USA
  • March 30 2018

The recently passed omnibus appropriations bill includes extensive funding, often at higher amounts than in fiscal year 2017, for many US healthcare


FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices
  • Morgan Lewis
  • USA
  • February 27 2018

The US Food and Drug Administration's new requirements for sponsors to follow Good Clinical Practices (GCPs) for ex-US device clinical trials will


A ‘More Than Peanuts’ Sentence Of Food Company Officials, Law360
  • Morgan Lewis
  • USA
  • February 6 2018

On Jan. 23, the Eleventh Circuit upheld the longest criminal sentences ever imposed in a food safety case. The court unanimously denied the appeals


International Life Sciences Review: Issue 8
  • Morgan Lewis
  • USA, Netherlands, China, European Union, France, Global
  • February 6 2018

The European Commission has published the Draft Regulation amending Regulation (EC) No 8472000 as regards the definition of the concept 'similar


FDA Doubles Down on Efforts to Develop Guidance for Clinical Trial Stakeholders
  • Morgan Lewis
  • USA
  • February 5 2018

The US Food and Drug Administration has updated its Information Sheet on payments to clinical trial subjects, including travel reimbursements, and


What Pharma Companies Need to Know about FDA’s New Draft IVD Guidance
  • Morgan Lewis
  • USA
  • January 24 2018

As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will


Amgen Moves to Dismiss Genentech’s Misrepresentation Claim
  • Morgan Lewis
  • USA
  • January 9 2018

Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act


District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation
  • Morgan Lewis
  • USA
  • December 7 2017

There have been two interpretations of the "acts of infringement" language in the patent venue statute regarding ANDA submissions in Hatch-Waxman