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Pharmacovigilance in Germany
  • Eversheds Sutherland (International) LLP
  • Germany, Global
  • December 19 2018

A structured guide to Pharmacovigilance in Germany

Failure to Report Adverse Events Results in Criminal Misbranding Settlement and Individual Liability
  • Skadden Arps Slate Meagher & Flom LLP
  • USA
  • December 14 2018

On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded

NHS research confirms what claimant lawyers already know.
  • Anthony Gold
  • United Kingdom
  • November 6 2018

Recently the NHS determined to have a look at why people take legal action. It is a late (some would say very late) but welcome addition to the debate

Plaintiffs’ Sanctions Request Emphatically Denied
  • Dechert LLP
  • USA
  • October 16 2018

In a classic case of overreaching, plaintiffs in the In re Abilify MDL, sought sanctions against the defendant for not preserving emails dating between 2002 and 2006...

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