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Results: 1-10 of 242

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


FDA Considers Removing Regulatory Obstacles to Generic Drug Competition
  • Sidley Austin LLP
  • USA
  • August 1 2017

On July 18, 2017, the Food and Drug Administration (FDA) held a public meeting1 to obtain input on steps it can take to encourage innovation in drug


FDA Announces Plans for Three Public Meetings and a Pilot Project Program Under the Drug Supply Chain Security Act
  • Sidley Austin LLP
  • USA
  • July 27 2017

On July 20, 2017, the Food and Drug Administration (FDA) published a notice announcing three public meetings entitled "Enhanced Drug Distribution


Ninth Circuit Affirms Viability of FCA Liability for Misrepresentations to FDA
  • Sidley Austin LLP
  • USA
  • July 18 2017

Both before and after the Supreme Court's decision in Escobar, courts have hesitated to accept "fraud on the FDA" theories of liability, which posit