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Results: 1-10 of 925

Seventh Circuit Holds That 2009 CMS Letter Triggered Public Disclosure Bar for Pre- and Post-Letter Conduct
  • Sidley Austin LLP
  • USA
  • August 16 2017

On August 8, 2017, the Seventh Circuit affirmed the dismissal of an FCA suit alleging that a psychiatric hospital ("Hartgrove") submitted claims to


U.S. Congress Reauthorizes Food and Drug Administration User Fee Programs, Acts on Other FDA Measures
  • Sidley Austin LLP
  • USA
  • August 15 2017

After more than two years of negotiations and just before the summer recess, the Senate voted to reauthorize the Food and Drug Administration's (FDA


FDA Considers Removing Regulatory Obstacles to Generic Drug Competition
  • Sidley Austin LLP
  • USA
  • August 1 2017

On July 18, 2017, the Food and Drug Administration (FDA) held a public meeting1 to obtain input on steps it can take to encourage innovation in drug


FDA Announces Plans for Three Public Meetings and a Pilot Project Program Under the Drug Supply Chain Security Act
  • Sidley Austin LLP
  • USA
  • July 27 2017

On July 20, 2017, the Food and Drug Administration (FDA) published a notice announcing three public meetings entitled "Enhanced Drug Distribution


EPA issues final framework rules for new chemical evaluation regulatory programme
  • Sidley Austin LLP
  • USA
  • July 24 2017

On June 22 2017 the Environmental Protection Agency (EPA) took historic action under the Toxic Substances Control Act, as amended last year by the


Ninth Circuit Affirms Viability of FCA Liability for Misrepresentations to FDA
  • Sidley Austin LLP
  • USA
  • July 18 2017

Both before and after the Supreme Court's decision in Escobar, courts have hesitated to accept "fraud on the FDA" theories of liability, which posit


Senate Continues to Negotiate Language to Repeal and Replace Affordable Care Act, Radically Restructure Medicaid
  • Sidley Austin LLP
  • USA
  • July 7 2017

On June 22, the U.S. Senate Budget Committee unveiled the draft Better Care Reconciliation Act of 2017 (BCRA), which would repeal and replace the


U.S. Centers for Medicare & Medicaid Services Requests Information Regarding Affordable Care Act Regulations
  • Sidley Austin LLP
  • USA
  • July 7 2017

On June 8, the Centers for Medicare & Medicaid Services (CMS) released a Request for Information (RFI) regarding the Affordable Care Act (ACA). The


U.S. Department of Health and Human Services Appoints Additional Leadership and Staff Positions
  • Sidley Austin LLP
  • USA
  • July 7 2017

Dr. Jerome Adams has been nominated to be Surgeon General. An anesthesiologist by background, Dr. Adams served as the Indiana state health


U.S. Congressional Budget Office Releases New Score for American Health Care Act; All Eyes on the Senate
  • Sidley Austin LLP
  • USA
  • July 7 2017

On May 24, the Congressional Budget Office (CBO) issued a revised score for the House-passed version of HR 1628, the American Health Care Act (AHCA