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Results: 11-20 of 53

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New FDA MDDS draft guidance reduces regulatory hurdles for software developers, signals continued intent to “regulate” software via policy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On June 20, 2014, FDA issued a draft guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications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On March 3, 2014, FDA issued a new draft guidance allowing manufacturers to distribute journal Articles, textbooks, and clinical practice guidelines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On November 25, 2013, the Food and Drug Administration (FDA) finalized its June 1, 2011 draft guidance on RUOIUO IVDs, omitting the most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


FDA proposes two safety rules governing imported foods
  • Sidley Austin LLP
  • USA
  • July 31 2013

On July 29, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") published two significant, long-awaited proposed rules mandated by


FDA issues draft guidance on medical device reporting (mdr) and answers industry questions on specific issues
  • Sidley Austin LLP
  • USA
  • July 10 2013

On July 8, 2013, the Food and Drug Administration (FDA) announced the availability of a draft guidance, "Medical Device Reporting for Manufacturers,"


FDA finalizes guidance to address potential bias and conflicts of interest in clinical investigations
  • Sidley Austin LLP
  • USA
  • March 1 2013

FDA has finalized its guidance on financial disclosure for clinical investigators. A draft of the guidance, published in May 2011, was developed in


Increased FDA scrutiny of pre-approval communications continued in 2012
  • Sidley Austin LLP
  • USA
  • February 5 2013

Warning and untitled letters issued to prescription drug manufacturers in 2012 reflect continued FDA focus on pre-approval communications. FDA's