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Results: 11-20 of 57

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On May 6, the Food and Drug Administration (FDA) announced it was withdrawing the 2004 draft guidance on "help-seeking" and other disease awareness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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach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


New FDA MDDS draft guidance reduces regulatory hurdles for software developers, signals continued intent to “regulate” software via policy
  • Sidley Austin LLP
  • USA
  • June 25 2014

On June 20, 2014, FDA issued a draft guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications


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


New FDA off-label guidance responds to industry petitions, raises significant issues
  • Sidley Austin LLP
  • USA
  • March 11 2014

On March 3, 2014, FDA issued a new draft guidance allowing manufacturers to distribute journal Articles, textbooks, and clinical practice guidelines


FDA final guidance on research use onlyinvestigational use only diagnostics shifts focus to manufacturer promotion
  • Sidley Austin LLP
  • USA
  • December 5 2013

On November 25, 2013, the Food and Drug Administration (FDA) finalized its June 1, 2011 draft guidance on RUOIUO IVDs, omitting the most


FDA says it will not actively regulate low-risk mobile medical apps
  • Sidley Austin LLP
  • USA
  • October 1 2013

On September 23, 2013, FDA issued final guidance on its approach to regulating "mobile medical apps" for smart phones, tablets, and other mobile