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Results:1-10 of 34

FDA: industry must address cybersecurity risks for medical devices.
  • Locke Lord 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


Attention pharmaceutical and medical device executives ignorance is not bliss
  • Locke Lord LLP
  • USA
  • October 31 2012

The recent sentencings of a number of executives on so-called "Park pleas" serve as an important reminder that the United States Department of Justice, working with the Food and Drug Administration, holds managers, officers, and in-house counsel at drug and medical device companies to a high standard with respect to overseeing the safe manufacture and delivery of drugs and medical devices to consumers.


Government addressing pharmaceutical and medical device manufacturing practices
  • Locke Lord LLP
  • USA
  • October 4 2012

Over-shadowed by record-breaking resolutions relating to off-label marketing has been the government turning to address pharmaceutical and medical device companies’ improper manufacturing practices through criminal investigations.


Medical device groups push for repeal of excise tax
  • Locke Lord LLP
  • USA
  • July 25 2011

In response to an upcoming excise tax that is expected to cost the medical device industry $2.7 billion per year, a group of more than 400 medical device companies and other organizations recently sent a letter to House and Senate leaders, asking for a repeal.


The “National Childhood Vaccine Injury Act” immunizes vaccine manufacturers from state design defect claims
  • Locke Lord LLP
  • USA
  • February 25 2011

On February 22, 2010, the U.S. Supreme Court held in Bruesewitz v. Wyeth that the National Childhood Vaccine Injury Act of 1986 (“NCVIA”) pre-empts state design defect common law claims against vaccine manufacturers for injury or death caused by a vaccine’s known and disclosed side effects.


Legislation introduced to alter PPACA; new NCQA medical home standards released; judge declares PPACA unconstitutional
  • Locke Lord LLP
  • USA
  • February 7 2011

On January 25, lawmakers in both the House and Senate introduced companion bills that would immediately repeal the $20 billion tax on medical devices that was included in the new healthcare reform law - the Patient Protection and Affordable Care Act (PPACA).


Healthcare news from Capitol Hill and the Department of Health and Human Services - February 7, 2011
  • Locke Lord LLP
  • USA
  • February 7 2011

On January 25, lawmakers in both the House and Senate introduced companion bills that would immediately repeal the $20 billion tax on medical devices that was included in the new healthcare reform law - the Patient Protection and Affordable Care Act (PPACA).


California court finds FDA-approved “investigational medical device” preempts state product liability law
  • Locke Lord LLP
  • USA
  • January 27 2011

The California Court of Appeal recently held that the Federal Medical Device Amendments Act (MDA) of 19761 preempts state product liability common law claims that challenge the safety or effectiveness of an investigational medical device previously approved for clinical testing by the FDA.


Therapeutic discovery project tax credit and cash grants of up to $5 million - application procedures released in IRS Notice 2010-45
  • Locke Lord LLP
  • USA
  • June 1 2010

IRS Notice 2010-45 was released on May 21, 2010 describing the application procedures for the new $1 billion investment tax credit and cash grants program for certain drug development or other medical advances by taxpayers not employing more than 250 employees.


Disclosure requirements for drug manufacturers, medical device companies and pharmacy benefit managers contained in health reform law
  • Locke Lord LLP
  • USA
  • April 27 2010

Effective March 31, 2013, a manufacturer of covered drugs, biologicals, medical devices or medical supplies that provides a payment or other transfer of value to a physician or a teaching hospital must report to the government the recipient, the amount of the payment or other transfer, a description of the payment or transfer, and the purpose of the payment or transfer.