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Results: 1-10 of 31

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


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 Delays Effective Date of Its Aggressive Final Rule on Intended Use
  • Sidley Austin LLP
  • USA
  • April 4 2017

On March 20, 2017, FDA announced a further delay of the effective date of its January 9, 2017, Final Rule entitled Clarification of When Products


New FDA Draft Guidance on Biosimilar Labeling Largely Follows Generic Drug Approach
  • Sidley Austin LLP
  • USA
  • April 7 2016

On March 31, the U.S. Food and Drug Administration (FDA) published its long-awaited draft guidance, "Labeling for Biosimilar Products." While the


Five Things To Know About The Amarin Settlement
  • Sidley Austin LLP
  • USA
  • March 31 2016

On March 8, 2016, Amarin Pharma, Inc., advised Judge Paul Engelmayer of the United States District Court for the Southern District of New York that


FDA Moves to Ban Powdered Gloves
  • Sidley Austin LLP
  • USA
  • March 28 2016

On March 22, the U.S. Food and Drug Administration (FDA) published a Federal Registernotice proposing to ban powdered surgeons' gloves, powdered


New Guidance Reflects Heightened FDA Focus on Medical Device Cybersecurity
  • Sidley Austin LLP
  • USA
  • January 26 2016

On January 15, 2016, the Food and Drug Administration (FDA) issued new guidance that, for the first time, recommends routine postmarketing


FDA proposal to drop knowledge prong of “intended use” rules grants long-standing industry request, with significant implications for off-label cases
  • Sidley Austin LLP
  • USA
  • September 29 2015

On September 25, 2015, the Food and Drug Administration (FDA) published in the Federal Register a proposal to amend its existing “intended use”


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