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Results: 1-10 of 423

Expedited FDA programs for development and approval of drugs and biologics

  • Hogan Lovells
  • -
  • USA
  • -
  • November 7 2014

For sponsors developing innovative drugs and biological products, understanding the regulatory programs available to expedite development and

CMS delays Health Plan ID enforcement, giving plans more time to comply

  • Hogan Lovells
  • -
  • USA
  • -
  • November 3 2014

On October 31, 2014, the U.S. Department of Health and Human Services (HHS) announced that it would delay, until further notice, enforcement of the

Conference on medical device and healthcare cybersecurity highlights new challenges

  • Hogan Lovells
  • -
  • USA
  • -
  • October 24 2014

The medical Internet of Things is coming. That was the common recognition of participants at a two-day public workshop on "Collaborative Approaches

Health and welfare plan compliance: health plan identifier deadline approaching

  • Hogan Lovells
  • -
  • USA
  • -
  • October 22 2014

We want to make our clients aware that, despite some criticism, the U.S. Department of Health and Human Services (HHS) is continuing to insist that

Final FDA guidance clarifies distinction between medical device recalls and enhancements

  • Hogan Lovells
  • -
  • USA
  • -
  • October 20 2014

On 15 October 2014, the Food and Drug Administration (FDA) issued its final guidance clarifying the difference between medical device recalls and

340B program: PhRMA files court challenge to interpretive rule on orphan drug exception

  • Hogan Lovells
  • -
  • USA
  • -
  • October 14 2014

On Thursday, October 9, 2014, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit against the Department of Health and Human

Ninth Circuit upholds Alameda County’s safe drug disposal ordinance

  • Hogan Lovells
  • -
  • USA
  • -
  • October 10 2014

On September 30, 2014, a three-judge panel of the United States Court of Appeals for the Ninth Circuit unanimously affirmed the U.S. District Court

Department of Health and human services Office of Inspector General proposes new anti-kickback safe harbors and exceptions to civil monetary penalties statute

  • Hogan Lovells
  • -
  • USA
  • -
  • October 8 2014

On 1 October 2014 the Department of Health and Human Services Office of Inspector General (OIG) published a proposed rule that would create three

340B program: Health Resources and Services Administration (HRSA) issues proposal to collect manufacturer data; comments due by Dec. 1, 2014

  • Hogan Lovells
  • -
  • USA
  • -
  • October 2 2014

On Tuesday, September 30, 2014, the Health Resources and Services Administration (HRSA), which administers the 340B program, published a Federal

OCR and NIST host conference and provide insights on safeguarding health information

  • Hogan Lovells
  • -
  • USA
  • -
  • October 1 2014

Government officials emphasized the importance of risk analysis and risk management in safeguarding PHI at the Seventh Annual "Safeguarding Health