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CMS issues proposed rules on federal "sunshine" law for manufacturers and GPOs
  • Epstein Becker Green
  • USA
  • December 16 2011

On December 14, 2011, the Centers for Medicare & Medicaid Services ("CMS") issued long-awaited proposed rules with a lengthy preamble (collectively referred to herein as "Proposed Rules") relevant to Section 6002 of the Patient Protection and Affordable Care Act, also known as the Physician Payment Sunshine Act

News Bytes
  • Shook Hardy & Bacon LLP
  • USA
  • March 20 2014

The U.S. Food and Drug Administration warns Institut Biochimique sA that the Facebook Web page for one of its drugs is false or misleading "because

Protecting e-mail as privileged attorney-client communication in drug and medical device litigation
  • Nelson Mullins Riley & Scarborough LLP
  • USA
  • April 17 2011

In recent drug and medical device litigation, the attorney-client privilege has come under attack

Parallel importation of medical devices: necessary repackaging vs “opportunistic” repackaging
  • Martini Manna Avvocati
  • Italy
  • July 8 2014

A permanent legal conflict is ongoing in the European Union between manufacturers and parallel importers of medical devices, in which single battles

Decree n2012-1095 of 28 September 2012 on various financial penalties which can be applied to companies operating medicines, and to manufacturers or distributors of medical devices
  • Hogan Lovells
  • France
  • October 31 2012

This Decree, which entered into force on 1 October 2012, relates to the implementation of three financial penalties applicable to companies manufacturing medicines or medical devices, reimbursable by medical insurance, and to distributors of medical devices in case of failures

Product liability - 9 July 2015
  • Baker McKenzie
  • Australia, European Union
  • July 9 2015

A ruling of the European Court of Justice (ECJ) in March 2015 has potentially significant consequences for manufacturers and importers of medical

Safety First: FDA Issues Draft Guidance for Manufacturers of Interoperable Medical Devices
  • Quarles & Brady LLP
  • USA
  • January 28 2016

The Food and Drug Administration (FDA) recently issued draft guidance on interoperable medical devices, entitled "Design Considerations and

FDA Finalizes Guidance on Postmarket Management of Medical Device Cybersecurity
  • Ropes & Gray LLP
  • USA
  • January 17 2017

On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices

FDA issues draft guidance on Medical Device Recalls
  • King & Spalding LLP
  • USA
  • February 28 2013

On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical

Medical device manufacturer pays $30 million to resolve FCA claims
  • Sidley Austin LLP
  • USA
  • October 21 2013

DOJ has announced a settlement agreement with medical device manufacturer Boston Scientific, alleging that its Guidant division caused the submission