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Results: 1-10 of 184

FDA proposes new user fees to finance food & cosmetic safety

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • April 12 2013

On April 10, 2013, the U.S. Food and Drug Administration ("FDA") announced a proposal that could increase the cost of doing business for the food and

Changes to HIPAA regulations affect employer-sponsored medical plans

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 27 2013

In January 2013, the Department of Health and Human Services (HHS) released final regulations updating the Health Insurance Portability and

DHHS and FDA officials respond to medical device mobile application regulatory concerns on final day of hearings

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 22 2013

The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications ("MMAs"

Day 2 of medical device mobile app hearings focuses on patient benefits

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 22 2013

The Health Subcommittee of the House of Representatives Energy and Commerce Committee held a second day of hearings regarding medical device mobile

House subcommittee holds Day 1 of hearings on medical device mobile apps

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 20 2013

The Communications and Technology subcommittee of the House of Representatives Energy and Commerce Committee held its first day of a three-day series

House Energy and Commerce Committee to hold hearings on regulation of medical device mobile applications

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 14 2013

The House of Representatives Committee on Energy and Commerce (the "Committee") is set to hold a three-day series of hearings next week regarding

Ninth Circuit rejects First Amendment defense in wire fraud case regarding drug misbranding

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 8 2013

This is a follow-up to our post late last year on the Second Circuit decision in US v. Caronia, which overturned a defendant's off-label marketing

New Jersey federal court dismisses false advertising class action alleging a lack of substantiation

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 6 2013

Last month, in Gaul v. Bayer Healthcare LLC, the U.S. District Court for the District of New Jersey dismissed a class action lawsuit predicated on

IOM report on counterfeit drugs released

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 4 2013

On February 13, 2013, the Institute of Medicine of the National Academies (IOM) released its report Countering the Problem of Falsified and

Supreme Court narrows the application of state-action doctrine immunity with ruling against a state hospital authority in FTC v. Phoebe Putney Health System, Inc.

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • February 19 2013

The Supreme Court today unanimously ruled that a purchase-and-lease transaction involving a county hospital authority acting under state law

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