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Results: 1-10 of 378

FDA, FCC, and ONC jointly issue highly anticipated health it report, recommending a three-tiered, risk-based approach to regulation

  • Hogan Lovells
  • -
  • USA
  • -
  • April 7 2014

The long-awaited joint report proposing an overarching framework for the regulation of health IT was issued on April 3, 2014, by the Food and Drug

FASEB guide on mitigating risk of animal rights extremism

  • Hogan Lovells
  • -
  • USA
  • -
  • March 25 2014

On 12 March, the Federation of American Societies for Experimental Biology (FASEB) released recommendations regarding response to threats by animal

Medical device development: regulation and law, 2014 edition

  • Hogan Lovells
  • -
  • USA
  • -
  • March 20 2014

Jonathan Kahan and the Hogan Lovells Medical Device practice have completed the 2014 edition of Medical Device Development: Regulation and Law, a

HHS reaches first settlement with local government over HIPAA violations

  • Hogan Lovells
  • -
  • USA
  • -
  • March 14 2014

The U.S. Department of Health and Human Services (HHS) sent a strong message to local governments last week when it reached a settlement with Skagit

The antitrust challenge to the St. Luke’sSaltzer Medical Group transaction: implications for hospitalphysician consolidations

  • Hogan Lovells
  • -
  • USA
  • -
  • March 10 2014

On January 24, 2014, the Federal Trade Commission (FTC), along with the Idaho Attorney General and two local hospitals, prevailed in Idaho District

FDA seeks comments on new Draft Guidance clarifying good reprint practices

  • Hogan Lovells
  • -
  • USA
  • -
  • March 10 2014

In a 3 March 2014 Federal Register notice, the U.S. Food and Drug Administration (FDA or the Agency) distributed a revised draft guidance

FDA finalizes guidance on drug CMC postapproval changes and allows more to be submitted in Annual Reports, instead of supplements

  • Hogan Lovells
  • -
  • USA
  • -
  • March 7 2014

Over the years, the number of chemistry, manufacturing, and controls (CMC) postapproval drug manufacturing supplements for NDAs and ANDAs submitted

Fourth Circuit holds that cGMP deficiencies alone do not constitute a False Claims Act violation

  • Hogan Lovells
  • -
  • USA
  • -
  • March 7 2014

For several years now current good manufacturing practice (cGMP) violations have been viewed as "the next hot thing" in False Claims Act (FCA

Actelion settles REMS dispute with generic drug manufacturers

  • Hogan Lovells
  • -
  • USA
  • -
  • March 6 2014

Last week Actelion settled a lawsuit against two generic drug manufacturers regarding whether Actelion is required to supply those generic firms with

FDA issues revised draft guidance on distributing scientific and medical publications on unapproved new uses

  • Hogan Lovells
  • -
  • USA
  • -
  • February 28 2014

Today, FDA announced the availability of a revised draft guidance, Distributing Scientific and Medical Publications on Unapproved New