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FDA releases new guidance on UDI direct marking requirements
  • Hogan Lovells
  • USA
  • June 30 2015

On June 26, 2015, FDA released a draft guidance document providing further clarification on the direct marking requirements associated with the


Supreme Court upholds federal health insurance subsidies
  • Hogan Lovells
  • USA
  • June 25 2015

Today, in a 6-3 ruling, the Supreme Court upheld the federal regulation that makes subsidies available to eligible individuals who purchase health


Supreme Court upholds federal health insurance subsidies
  • Hogan Lovells
  • USA
  • June 25 2015

Today, in a 6-3 ruling, the Supreme Court upheld the federal regulation that makes subsidies available to eligible individuals who purchase health


FDA publishes final guidance on physical attributes of generics
  • Hogan Lovells
  • USA
  • June 18 2015

FDA today published a final version of its guidance, "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules," with only minor


OIG issues new Advisory Opinion on donations to independent charitable foundation patient assistance programs
  • Hogan Lovells
  • USA
  • June 18 2015

Many manufacturers and providers donate to independent charitable foundation patient assistance programs (PAPs) that help financially needy patients


340B Program: HRSA releases proposed rule on calculation of the ceiling price and imposition of civil monetary penalties on manufacturers
  • Hogan Lovells
  • USA
  • June 16 2015

Today, the Health Resources and Services Administration (HRSA) released a Notice of Proposed Rulemaking (NPRM) regarding the calculation of the 340B


CMS releases final rule for accountable care organizations in the Medicare Shared Savings Program
  • Hogan Lovells
  • USA
  • June 8 2015

On June 4, 2015, CMS issued a final rule updating the Medicare Shared Savings Program (MSSP). Under the MSSP, Accountable Care Organizations (ACOs


Medicaid and Children's Health Insurance Program (CHIP) managed care proposed rule
  • Hogan Lovells
  • USA
  • June 3 2015

On June 1, 2015, the Centers for Medicare & Medicaid Services (CMS) published its much-anticipated proposed rule to revisefor the first time


Health IT regulator updates guidance on privacy and security
  • Hogan Lovells
  • USA
  • May 27 2015

In an effort to help members of the health IT community better understand the federal laws relating to interoperability, the Office of the National


New draft guidance outlines FDA’s key considerations for adaptive designs in clinical studies
  • Hogan Lovells
  • USA
  • May 22 2015

On May 18, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Adaptive Designs for Medical Device Clinical Studies