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Human subjects research protections proposed rule finally moves forward for White House review

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 25 2015

On February 24, the Office of Management and Budget's Office of Internal Regulatory Affairs (OIRA) accepted for review the Department of Health and

Opportunities for participation in the new Precision Medicine Initiative

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 19 2015

The President recently announced the creation of a new "Precision Medicine Initiative" to "revolutionize how we improve health and treat disease"

Antitrust enforcement in the medical device sector - ten areas of focus in 2015

  • Sidley Austin LLP
  • -
  • China, European Union, USA
  • -
  • February 18 2015

Enforcement agencies and courts in the United States and Europe have long dealt with high-profile antitrust cases in the pharmaceutical sector

CMS delays final overpayments rule until 2016

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 16 2015

On Friday, February 13, 2015, CMS announced that it needs at least one more year to finalize regulations governing the report and return of

CMS issues guidance on reporting and refunding of overpayments actionable under the FCA

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 16 2015

On February 16, 2012, the Centers for Medicare and Medicaid Services ("CMS") released a long-awaited proposed rule ("Proposed Rule") to implement the

Recent changes and proposal related to the Medicare Part D program signal increased costs to pharmaceutical industry

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 13 2015

Last week, there were two separate key developments related to the Medicare Part D program. On February 2, President Obama released the Fiscal Year

FTC and DOJ solicit comments for health care competition workshop

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 30 2015

Late last week, the Federal Trade Commission and the Department of Justice (collectively, the Agencies) announced that they will hold a public

HHS plans for faster Medicare shift to value-based purchasing

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 28 2015

Earlier this week, the Secretary of Health and Human Services (HHS), Sylvia Burwell, made a significant announcement regarding Medicare's planned

FDA addresses oversight of general wellness products, device accessories

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 22 2015

On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach

Updates on clinical laboratory reimbursement and enforcement

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 14 2015

In recent weeks the Centres for Medicare and Medicaid Services released several significant updates affecting reimbursement for clinical laboratory