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Clinical trials in the USA
  • Perkins Coie LLP
  • Global, USA
  • February 24 2017

A structured guide to clinical trials in the USA

Final Guidance Sheds Light on Medical Device Reporting Requirements
  • Haynes and Boone LLP
  • USA
  • February 15 2017

In November 2016, the U.S. Food and Drug Administration ("FDA") issued a final guidance on medical device reporting for manufacturers ("Final MDR

St. Jude Cybersecurity Vulnerability Extended to Provider-Owned Devices
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • February 9 2017

Earlier this week, the U.S. Department of Homeland Security (DHS) updated a prior advisory revealing cybersecurity vulnerabilities in St. Jude

Trump’s 2-for-1 Executive Order and its Impact on FDA
  • Arent Fox LLP
  • USA
  • February 3 2017

On the heels of a January 20, 2017 memorandum freezing the release of any new or pending regulations until they have been reviewed and approved by

FTC Cries Foul On Breathometer Accuracy Claims
  • Kelley Drye & Warren LLP
  • USA
  • February 1 2017

The FTC recently announced a settlement with Breathometer, Inc., a company that marketed a smartphone accessory that it claimed could detect blood

False Claims Act: 2016 Year-in-Review
  • Wilmer Cutler Pickering Hale and Dorr LLP
  • USA
  • February 1 2017

In 2016, the Department of Justice (DOJ) continued to give high priority to False Claims Act (FCA) investigations and prosecutions. The government

The Secret's Out: FDA Allows Drug and Device Manufacturers to Share HCEI Prior to Product Approval
  • Arent Fox LLP
  • USA
  • January 23 2017

Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities -

Regulatory Developments Life Sciences Companies Should Expect in the New Presidential Administration
  • Jones Day
  • USA
  • January 20 2017

2017 and beyond promises to be a time for continued evolution and uncertainty for life sciences companies doing business in the United States. In

The State AG Report Weekly Update January 19, 2017
  • Cozen O'Connor
  • USA
  • January 19 2017

New York AG Eric Schneiderman reached an agreement with Citigroup subsidiary Citigroup Global Markets, Inc. (“CGMI”) to resolve allegations that the

What You Need To Know About the FDA’s Guidance on Postmarket Cybersecurity
  • Reed Smith LLP
  • USA
  • January 18 2017

The FDA released its final Guidance on Postmarket Management of Cybersecurity in Medical Devices during the week between Christmas and New Year. You