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Results: 1-10 of 44

FDA Gauges Coverage Organizations’ Interest in Connecting with Device Sponsors to Discuss Evidence Needs During Clearance Process
  • Reed Smith LLP
  • USA
  • February 24 2016

The FDA published a notice on February 24, 2016 requesting whether organizations (e.g. Insurers, health technology assessment organizations) that


Senate HELP Committee Clears Bipartisan Biomedical Innovation, Health IT Bills
  • Reed Smith LLP
  • USA
  • February 23 2016

The Senate Health, Education, Labor and Pensions (HELP) Committee has approved several bipartisan health policy bills, including health information


President Obama Signs Bill to Restrict Use of Microbeads in Cosmetics
  • Reed Smith LLP
  • USA
  • January 12 2016

President Obama has signed into law H.R. 1321, the "Microbead-Free Waters Act of 2015." The new law prohibits the manufacture, sale, or distribution


FDA to Hold Medical Device Cybersecurity Workshop (Jan 20-21)
  • Reed Smith LLP
  • USA
  • December 10 2015

As discussed on our sister Life Sciences Legal Update blog, the FDA is holding a public two-day workshop entitled “Moving Forward: Collaborative


FDA releases "Purple Book," including biosimilar products
  • Reed Smith LLP
  • USA
  • October 6 2014

The FDA's new "Purple Book" lists biological products licensed by FDA under the Public Health Service Act (the PHS Act). The publication includes


FDA meeting on biomarker development (Sept. 5)
  • Reed Smith LLP
  • USA
  • July 22 2014

On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and


FDA releases drugdevice industry social media guidance documents
  • Reed Smith LLP
  • USA
  • June 23 2014

The FDA released two draft social media guidance documents last week, describing how manufacturers, packers and distributors of prescription drugs


FDA to hold workshop on accessible standardized medical device labeling (April 29-30)
  • Reed Smith LLP
  • USA
  • January 11 2013

On April 29 and 30, 2013, the Food and Drug Administration (FDA) is hosting a public workshop on "Accessible Standardized Medical Device Labeling." The


GAO flags concerns about implantable medical device information security
  • Reed Smith LLP
  • USA
  • October 16 2012

A recent GAO report warns of information security risks such as unauthorized changes of device settings resulting from a lack of appropriate access controls -- associated with the growing use of wireless technology in certain active implantable medical devices (e.g., implantable cardioverter defibrillators and insulin pumps


OIG examines dietary supplement claims, registration with FDA
  • Reed Smith LLP
  • USA
  • October 16 2012

The OIG has released two reports focusing on dietary supplements, one examining labeling claims and the other reviewing the FDA’s ability to identify and contact manufacturers in a public health emergency