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Results: 1-10 of 245

FDA Proposes Rule on Combination Product Jurisdiction
  • Sidley Austin LLP
  • USA
  • May 22 2018

On Tuesday, May 15, 2018, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend its regulations concerning how medical


DOJ Confirms Involvement in Opioid Litigation, Sheds Light on Potential Claims
  • Sidley Austin LLP
  • USA
  • March 9 2018

In a series of speeches over the last week, DOJ has expanded on its commitment to organize enforcement efforts focused on manufacturers and


Second Circuit finds government's continued payment in face of fraud allegations undercuts materiality
  • Sidley Austin LLP
  • USA
  • January 31 2018

In Universal Health Services v United States ex rel Escobar the Supreme Court emphasised that questions of materiality are not "too fact


Second Circuit Finds That The Government’s Continued Payment In The Face of Fraud Allegations Undercuts Materiality
  • Sidley Austin LLP
  • USA
  • January 2 2018

The Supreme Court emphasized in Escobar that questions of materiality are not "too fact intensive for courts" to decide through a motion to dismiss


China FDA Proposes Sweeping Rules to Regulate Medical Representatives
  • Sidley Austin LLP
  • China
  • December 28 2017

In January 2017, China's State Council announced that the medical representative (MR) profession would be subject to two new requirements. One


U.S. Food and Drug Administration Proposes Changes to the Premarket Pathway for Genetic Health Risk Tests
  • Sidley Austin LLP
  • USA
  • November 10 2017

On Nov. 8, 2017, the Food and Drug Administration (FDA) published two final orders and a notice related to direct-to-consumer (DTC) genetic tests


U.S. Food and Drug Administration Issues Final Guidance On Changes Related to Cleared Medical Device
  • Sidley Austin LLP
  • USA
  • November 8 2017

After one false start, congressional intervention, a report to Congress and a relatively short interval between draft and final version of the


FDA Announces Regulatory and Enforcement Policy Shift for Regenerative Medicine
  • Sidley Austin LLP
  • USA
  • September 13 2017

On August 28, 2017, FDA Commissioner Scott Gottlieb announced a significant shift in the way the Agency intends to regulate stem cell therapies and


U.S. Congress Reauthorizes Food and Drug Administration User Fee Programs, Acts on Other FDA Measures
  • Sidley Austin LLP
  • USA
  • August 15 2017

After more than two years of negotiations and just before the summer recess, the Senate voted to reauthorize the Food and Drug Administration's (FDA


U.S. Food and Drug Administration Announces New Tobacco Policies Acknowledging the Role of Harm Reduction
  • Sidley Austin LLP
  • USA
  • August 8 2017

On what should have been a quiet Friday in late July, the Food and Drug Administration (FDA) revealed a number of new policies, representing arguably