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Materiality Part II: Government Knowledge
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • January 3 2018

This is the second in a five-part series on how U.S. district courts and courts of appeal have applied the materiality standard set forth in Universal

Pharmacovigilance in Germany
  • Eversheds Sutherland (International) LLP
  • Germany, Global
  • October 19 2017

A structured guide to Pharmacovigilance in Germany

Third Circuit Provides New Guidance on Escobar’s Materiality Requirement in Healthcare Cases
  • Sidley Austin LLP
  • USA
  • May 24 2017

In a recent opinion, the Third Circuit provided new guidance on the application of Escobar's "heightened" materiality standard to cases involving

New Open Access to FDA Data on Adverse Events - How can the Industry Respond?
  • Baker McKenzie
  • USA
  • February 28 2017

The United States' Food and Drug Administration (FDA) has announced that the agency has created a user-friendly forum providing free access to

FDA Hits “Pause” on Regulation of LDTs
  • Foley & Lardner LLP
  • USA
  • February 12 2017

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion

FDA's flurry of food and cosmetic activities continues unabated
  • Sidley Austin LLP
  • USA
  • February 1 2017

As the Obama administration drew to a close, the Food and Drug Administration's Centre for Food Safety and Applied Nutrition (CFSAN) continued to

FDA's Flurry of Food and Cosmetic Activities Continues Unabated
  • Sidley Austin LLP
  • USA
  • January 9 2017

As the Obama administration draws to a close, the Food and Drug Administration's (FDA) Center for Food Safety and Applied

New OIG Investigations to Look at Wide Range of Medicare, Medicaid Services in FY 2017
  • Reed Smith LLP
  • USA
  • November 21 2016

The HHS Office of Inspector General (OIG) has issued its FY 2017 Work Plan, which lays out the OIG’s current audit, evaluation, and other legal and

FDA Working to Modernize Medical Device Reporting in Hospitals
  • Squire Patton Boggs
  • USA
  • November 1 2016

Recent medical device adverse events prompted FDA to take a fresh look at the ways it collects data related to medical device adverse events from

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