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Results: 1-10 of 647

District court grants partial dismissal in Part DMedicaid case alleging false comparative marketing claims
  • Sidley Austin LLP
  • USA
  • August 25 2015

On August 20, 2015, the District of New Jersey granted in part and denied in part defendants' motion to dismiss allegations that by making


China reforms its review and approval systems for drugs and medical devices
  • Sidley Austin LLP
  • China
  • August 19 2015

On August 18, 2015, China's State Council issued an important document, the Opinions on Reforming Review and Approval Process for Drugs and Medical


District Court holds that First Amendment bars prosecution for misbranding where conduct is truthful, non-misleading speech about off-label uses, declines to rule on potential FCA liability
  • Sidley Austin LLP
  • USA
  • August 10 2015

On August 7, in the first Caronia progeny case, the United States District Court for the Southern District of New York (Engelmayer, J.) granted


FDA loses Amarin litigation; court grants preliminary relief
  • Sidley Austin LLP
  • USA
  • August 10 2015

In a widely anticipated ruling on Friday, in the ongoing Amarin litigation against the United States Food and Drug Administration (FDA), Judge


Release of the new Singapore Ethics Guidelines for Human Biomedical Research
  • Sidley Austin LLP
  • Singapore
  • August 4 2015

On June 23, 2015, the Bioethics Advisory Committee (BAC) established by the Singapore government to recommend policies based on the ethical and legal


CFDA proposes new initiatives to improve and reform its drug review system
  • Sidley Austin LLP
  • China
  • August 4 2015

On July 31, 2015, the China Food and Drug Administration (CFDA) published a draft policy paper for public comments by August 15, 2015, proposing new


District court denies motion to dismiss in government’s groundbreaking overpayment suit
  • Sidley Austin LLP
  • USA
  • August 4 2015

On August 3, Judge Ramos of the Southern District of New York denied the motion to dismiss of defendant hospitals ("Continuum") accused of failing to


CFDA requires immediate self-inspection of clinical trial data for pending drug registrations
  • Sidley Austin LLP
  • China
  • July 28 2015

On July 22, 2015, the China Food and Drug Administration (CFDA) issued a far-reaching Circular mandating applicants for a total of 1,622 pending drug


Precision Medicine Initiative: Proposed Privacy & Trust Principles
  • Sidley Austin LLP
  • USA
  • July 15 2015

The White House is soliciting public comments on its Proposed Privacy and Trust Principles (the Proposed Principles) for the Precision Medicine


Court declares no HIPAA violation for relators who retained protected health information
  • Sidley Austin LLP
  • USA
  • July 14 2015

A recent opinion examines the interplay between the Health Insurance Portability and Accountability Act ("HIPAA") and the False Claims Act ("FCA"