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Results: 11-20 of 62

FDA continues scrutiny of DTC genetic testing by clinical labs
  • Sidley Austin LLP
  • USA
  • November 17 2015

The U.S. Food and Drug Administration (FDA) recently released three untitled letters from the Office of In Vitro Diagnostics and Radiological Health


FDA releases draft guidance, sets public hearing on regulation of HCTPs
  • Sidley Austin LLP
  • USA
  • November 3 2015

On October 29, the Food and Drug Administration (FDA) released a draft guidance titled “Homologous Use of Human Cells, Tissues, and Cellular and


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


FDA withdraws 2004 disease awareness guidance
  • Sidley Austin LLP
  • USA
  • May 7 2015

On May 6, the Food and Drug Administration (FDA) announced it was withdrawing the 2004 draft guidance on "help-seeking" and other disease awareness


FDA takes additional steps to address West Africa Ebola outbreak
  • Sidley Austin LLP
  • Africa, USA
  • March 25 2015

On March 16, 2015, the Food and Drug Administration (FDA) issued a revised Emergency Use Authorization (EUA) for Corgenix Inc.'s ReEBOV Antigen Rapid


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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach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 affirms permissive comparative claim policies, while establishing foundation for restrictive guidance
  • Sidley Austin LLP
  • USA
  • September 22 2014

Food and Drug Administration (FDA) officials recently affirmed that prescription drug manufacturers may make comparative promotional claims regarding


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