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Results:1-10 of 47

FDA Issues New Draft Guidance on “Least Burdensome” Principles for Medical Devices
  • Drinker Biddle & Reath LLP
  • USA
  • December 21 2017

On December 15, the U.S. Food & Drug Administration (FDA) issued “The Least Burdensome Provisions: Concept and Principles: Draft Guidance for Industry


FDA issues guidance on cybersecurity for medical devices
  • Drinker Biddle & Reath LLP
  • USA
  • November 24 2014

On October 2, the FDA issued guidance on cybersecurity for medical devices containing software in order "to assist industry by identifying issues


Overhaul of FCC experimental licensing rules
  • Drinker Biddle & Reath LLP
  • USA
  • May 29 2013

In an attempt to bring clarity to its current experimental licensing rules and policies, and to expand the opportunities for manufacturers and


Privately held medical device and drug companies face unique Sunshine Act challenges
  • Drinker Biddle & Reath LLP
  • USA
  • May 17 2013

As widely reported, the Centers for Medicare and Medicaid Services ("CMS") recently issued regulations implementing the Sunshine Act provisions of


The perils and promise of 3D printing: are DIY life sciences in your future?
  • Drinker Biddle & Reath LLP
  • USA
  • May 13 2013

With news that 3D printing (without question one of the coolest technologies to come down the road in quite some time) can be used to produce guns


Proposed new requirements on FDA acceptance of data from clinical studies for medical devices
  • Drinker Biddle & Reath LLP
  • USA
  • March 13 2013

On February 25, 2013, the FDA proposed new regulations to amend its current requirements on the acceptance of clinical data for medical devices


CMS’s final “sunshine” rule: implications for research
  • Drinker Biddle & Reath LLP
  • USA
  • February 14 2013

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released its long-awaited final rule (Final Rule) implementing Section 6002


Massachusetts refines its sunshine law; final federal sunshine regulations moving ahead
  • Drinker Biddle & Reath LLP
  • USA
  • December 5 2012

The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level.


Fiscal cliff, taxmageddon, sequestration what does it all mean?
  • Drinker Biddle & Reath LLP
  • USA
  • November 13 2012

Now that the election is over, the President, the U.S. Congress, the media, and the financial markets have shifted their attention to the impending economic calamity that Congress created and that Congress must fixotherwise the country will tumble off the “fiscal cliff.”


Newly reissued Iran sanctions add general license for medical devices
  • Drinker Biddle & Reath LLP
  • USA
  • November 2 2012

On October 22, 2012, the Office of Foreign Assets Control (“OFAC”) reissued in its entirety and renamed the Iranian Transactions and Sanctions Regulations (“ITSR”) at 31 C.F.R. Part 560, previously titled the Iranian Transactions Regulations.