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US: Federal Circuit denies venue transfer in TC Heartland
  • Hogan Lovells
  • USA
  • May 25 2016

In follow up to our earlier post the Court of Appeals for the Federal Circuit has denied TC Heartland LLC’s (“TC”) petition for a writ of mandamus to


Federal Court Determines that Patient Has Liberty Interest in Receiving Investigational Drug
  • Hogan Lovells
  • USA
  • May 24 2016

On May 17, 2016, a federal judge, citing arbitrary and capricious decisionmaking by FDA and notice-based due process concerns, granted a plaintiff's


FDA Releases New Draft Guidance Document on 3D Printing of Medical Devices
  • Hogan Lovells
  • USA
  • May 19 2016

Additive Manufacturing (AM), commonly known as 3D printing, is increasingly being used in the manufacture of medical devices, including orthopedic


FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations
  • Hogan Lovells
  • USA
  • May 19 2016

On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on


New FDA Guidance on Section 522 Postmarket Surveillance Studies
  • Hogan Lovells
  • USA
  • May 16 2016

Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.1 This new guidance document provides clarifications regarding


District Court Delivers Blow to Affordable Care Act
  • Hogan Lovells
  • USA
  • May 13 2016

On Thursday, May 12, 2016, the United States District Court for the District of Columbia ruled against the Obama Administration and in favor of the


Be Prepared for California's Prop 65 BPA Warnings
  • Hogan Lovells
  • USA
  • May 11 2016

Beginning May 11, 2016, California's Office of Environmental Health Hazard Assessment (OEHHA) will start requiring warnings for consumer products


Higher Quality of Care Equals Higher Quantity of Payment in MACRA Proposed Rule
  • Hogan Lovells
  • USA
  • May 4 2016

Have they concocted the perfect Formula? Last week, the Centers for Medicare & Medicaid Services (CMS) took the next step toward creating a new


Cybersecurity in the Health Sector
  • Hogan Lovells
  • USA
  • May 2 2016

The health sector is under siege with cybersecurity threats. Some of the largest announced cyber attacks in U.S. history have targeted organizations


Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Final Rule
  • Hogan Lovells
  • USA
  • April 27 2016

On April 25, 2016, the Centers for Medicare & Medicaid Services (CMS) released the much-anticipated final rule ("Final Rule") updating the Medicaid