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Results: 1-10 of 25

FDA proposes electronic distribution of prescribing information

  • Baker & Hostetler LLP
  • -
  • USA
  • -
  • January 15 2015

Drug manufacturers may no longer be required to distribute prescribing information on paperwith limited exceptionsand instead may have

114th Congress outlook

  • Hogan Lovells
  • -
  • USA
  • -
  • January 8 2015

It is very likely that the year 2015 will see the enactment of some kind of federal tax legislation. Given the wide chasm between the goals (political

Another ediscovery front?

  • Reed Smith LLP
  • -
  • USA
  • -
  • December 29 2014

On December 18, the FDA published its proposed rule for replacing the venerable package insert with "electronic" prescribing information. The cite is

Cybersecurity and products liability: an update

  • Weil Gotshal & Manges LLP
  • -
  • USA
  • -
  • December 24 2014

In the wake of recent data breaches, it is an appropriate time to revisit the topic of cybersecurity from a product liability perspective. In the

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 30 2014

The U.S. Food and Drug Administration (FDA) makes available Guidance for Industry titled "Circumstances that Constitute Delaying, Denying, Limiting

FDA to hold webinar on cybersecurity in medical devices guidance

  • Taft Stettinius & Hollister LLP
  • -
  • USA
  • -
  • October 28 2014

On Oct. 29, 2014, the United States Food and Drug Administration (FDA) will hold a webinar on its Final Guidance "Content of Premarket Submissions

FDA issues cybersecurity guidelines manufacturers of medical devices encouraged to develop cybersecurity controls

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 27 2014

The Food and Drug Administration (FDA) issued guidelines this month recommending that manufacturers develop a set of cybersecurity controls in the

Medical device regulation in cyberspace

  • Davis LLP
  • -
  • Canada, USA
  • -
  • October 16 2014

When designing any electronic tool, whether it be a smart phone or a game console, it is always important for the manufacturer to strike a balance

FDA: industry must address cybersecurity risks for medical devices.

  • Edwards Wildman Palmer LLP
  • -
  • USA
  • -
  • October 3 2014

On October 1, 2014 the U.S. Food and Drug Administration finalized guidance on recommendations to manufacturers for managing cybersecurity risks to

Expect focus - volume III, Summer 2014

  • Carlton Fields Jorden Burt
  • -
  • USA
  • -
  • September 16 2014

EXPECTFOCUS is a quarterly review of developments in the insurance and financial services industry, provided on a complimentary basis to clients and