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Results: 1-10 of 419

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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach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

Notice of proposed rulemaking on clinical trial registration and results submission

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 7 2015

On November 21 2014 the National Institutes of Health (NIH) published a proposed rule that would expand the clinicaltrials.gov registration and

EU Court of Justice settles debate about patentability of inventions using parthenotes

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • December 22 2014

On December 18, 2014, the Court of Justice of the EU (Court) opened the door for more stem cell patents by fine-tuning its definition of a "human

CFPB investigating medical debt information reported to consumer reporting agencies

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 17 2014

The Consumer Financial Protection Bureau (CFPB) has announced that it is requiring consumer reporting agencies to provide information regarding which

New FTC settlement reveals heightened agency scrutiny regarding patient authorizations and the collection of health information

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 16 2014

On December 3, 2014, the Federal Trade Commission (FTC) announced that it reached a settlement with PaymentsMD, an Atlanta-based medical billing

EU publishes new GMP Regulation and guidelines

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • December 11 2014

The European Commission's long-awaited Delegated Regulation on Good Manufacturing Practice (GMP) principles and guidelines for active substances for

China is developing guidelines for multi-regional clinical trials

  • Sidley Austin LLP
  • -
  • China
  • -
  • December 2 2014

On November 21, 2014, the China Food and Drug Administration (CFDA) published a draft guideline on multi-regional clinical trials (MRCT) (the "MRCT