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Pharmacovigilance in Germany
  • Eversheds Sutherland (International) LLP
  • Germany, Global
  • July 9 2018

A structured guide to Pharmacovigilance in Germany


Federal Right To Try Legislation - Is It Any Better? - 2018 Edition
  • Reed Smith LLP
  • USA
  • March 23 2018

A little more than six months ago, we reviewed then-pending federal right-to-try legislation. Since then it’s become a shiny object, capable of


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


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