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FDA Offers New Recommendations for Interoperability of Connected Devices
  • Hogan Lovells
  • USA
  • February 1 2016

On January 26, 2016, the Food and Drug Administration ("FDA" or the "Agency") released a draft guidance document, Design Considerations and


Medicaid Drug Rebate Program: CMS releases final covered outpatient drug regulation
  • Hogan Lovells
  • USA
  • January 28 2016

The Centers for Medicare & Medicaid Services (CMS) released the final Medicaid covered outpatient drug regulation on Thursday, January 21, 2016. The


US - Supreme Court to review PTAB claim construction standard
  • Hogan Lovells
  • USA
  • January 26 2016

On January 15, 2016, the U.S. Supreme Court decided to review whether the Patent Trial & Appeal Board ("PTAB") has been using the correct standard to


Supreme Court Holds In Montanile That A Beneficiary’s Dissipation Defeats An ERISA Plan’s Reimbursement Claim. Now What?
  • Hogan Lovells
  • USA
  • January 21 2016

The Supreme Court held yesterday in Montanile v. Board of Trustees of the National Elevator Industry Health Benefit Plan, in which we represented the


When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices
  • Hogan Lovells
  • USA
  • January 21 2016

This past year, FDA’s (Center for Devices and Radiological Health CDRH) has dealt with several widely-publicized public health issues related to


FDA Offers Clarity of UDI Application to Kits
  • Hogan Lovells
  • USA
  • January 8 2016

On January 4, 2016, FDA officially released a draft guidance document Unique Device Identification: Convenience Kits, with further information


Pacira settlement could have ripple effects on a range of FDA issues far beyond promotional claims
  • Hogan Lovells
  • USA
  • January 7 2016

We continue to examine the Pacira case documents and give this settlement in-depth thought across all areas of our FDA regulatory practice. As we


Congress Suspends Medical Device Tax for Two Years
  • Hogan Lovells
  • USA
  • December 23 2015

The tax and spending bill signed into law by President Obama last week included a two year suspension of the medical device excise tax. After years


FDA Settles Pacira’s First Amendment Lawsuit
  • Hogan Lovells
  • USA
  • December 17 2015

Pacira has announced that it settled its lawsuit against FDA over the labeling and promotion of its postsurgical analgesic drug, EXPAREL. FDA


‘Tis the Season . . . to Prepare for Phase 2 HIPAA Audits
  • Hogan Lovells
  • USA
  • December 17 2015

Though the U.S. Department of Health and Human Services Office for Civil Rights (OCR) has told organizations to expect the Phase 2 HIPAA audits soon