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Results: 1-10 of 28

New FDA Draft Guidance on Biosimilar Labeling Largely Follows Generic Drug Approach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On March 31, the U.S. Food and Drug Administration (FDA) published its long-awaited draft guidance, "Labeling for Biosimilar Products."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”


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


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 addresses oversight of general wellness products, device accessories
  • Sidley Austin LLP
  • USA
  • January 22 2015

On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach


FDA moves forward with program for Medical Device Development Tools
  • Sidley Austin LLP
  • USA
  • September 8 2014

On August 15, 2014, FDA announced that it is soliciting proposals to participate in a pilot program for Medical Device Development Tools (MDDTs


Decoding FDA: five things to know about the FDA’s June 6 response to the MIWG citizen petition concerning off-label promotion
  • Sidley Austin LLP
  • USA
  • June 18 2014

On June 6, 2014, FDA sent a letter to counsel for the Medical Information Working Group (MIWG), a coalition of biopharmaceutical and medical