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Results: 1-10 of 1,004

CMS Request for Information Presents Rare Opportunity for Medicare Stakeholder Engagement
  • Hogan Lovells
  • USA
  • April 24 2017

On 14 April 2017, the Centers for Medicare & Medicaid Services (CMS) published the fiscal year (FY) 2018 Medicare Hospital Inpatient Prospective


Just One More Day: Compliance Deadline for New ClinicalTrials.gov Regulations is Tuesday, 18 April 2017
  • Hogan Lovells
  • USA
  • April 17 2017

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for


FDA Cleared First DTC Genetic Tests for Health Risks
  • Hogan Lovells
  • USA
  • April 17 2017

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe's Personal Genome Service (PGS) Test for 10


Court Upholds DOJ Antitrust Lawsuit Challenging Carolinas Healthcare System’s Anti-Steering Provisions
  • Hogan Lovells
  • USA
  • April 6 2017

Despite a recent decision by the Second Circuit suggesting that anti-steering contractual provisions in other industries may not be anticompetitive


Calling for Ideas - CMS Releases Final 2018 Medicare Advantage and Part D Rate Announcement and Call Letter
  • Hogan Lovells
  • USA
  • April 5 2017

On 3 April 2017, the Centers for Medicare & Medicaid Services (CMS) released its final Medicare Advantage (MA) and Part D Rate Announcement and Call


340B Program: Ceiling Price and CMP Final Rule Delayed Until May 22--Comments Requested on Possible Further Delay
  • Hogan Lovells
  • USA
  • March 20 2017

On 20 March 2017, the Health Resources and Services Administration (HRSA) published an Interim Final Rule (IFR) delaying the effective date of the


CFIUS Reform Turns to Food Security
  • Hogan Lovells
  • USA
  • March 20 2017

Congressional efforts to reform the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee that


EU - US mutual recognition of GMP inspections: agreement published
  • Hogan Lovells
  • European Union, USA
  • March 20 2017

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal


Guide to Recent Biosimilar Activity by FDA and in the Supreme Court
  • Hogan Lovells
  • USA
  • March 16 2017

The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final


Republicans release much anticipated ACA "repeal and replace" bill, but will it fly under the Byrd rule?
  • Hogan Lovells
  • USA
  • March 7 2017

On 6 March 2017, House Republicans in the Committee on Ways and Means and the Committee on Energy and Commerce introduced the American Health Care