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Results:1-10 of 917

Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”
  • Seyfarth Shaw LLP
  • USA
  • October 24 2018

The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs


FDA schedules public hearing on solutions to drug shortages
  • Hogan Lovells
  • USA
  • October 8 2018

FDA schedules public hearing on solutions to drug shortages October 08, 2018 The U.S. Food and Drug Administration (FDA) has announced it will hold a


CMS Allows Medicare Part D Indication-Based Formulary Design
  • Holland & Knight LLP
  • USA
  • August 30 2018

The Centers for Medicare and Medicaid Services (CMS) has just announced a significant shift in Medicare Part D formulary design to allow Part D


Health Canada invites public comments on new post-market reporting regulations
  • Gowling WLG
  • USA, Canada
  • August 9 2018

The medical device industry in America and perceived shortcomings in the US Food and Drug Administration's ("FDA") approval process have recently come


House Passes 12 Bills Aimed at Combating Opioid Crisis
  • Quarles & Brady LLP
  • USA
  • June 13 2018

On Tuesday, the House of Representatives passed a fleet of bills aimed at combating the ongoing opioid crisis, most aimed at developing preventative


Washington Healthcare Update - May 21, 2018
  • McGuireWoods LLP
  • USA
  • May 21 2018

On May 17, the Energy and Commerce Committee held the second of its opioid legislation markups, clearing 32 bills. The previous markup reported out 25


President set to outline drug pricing plan: how far will it go?
  • Cooley LLP
  • USA
  • May 10 2018

Tomorrow at 2 p.m., EST, the President is scheduled to deliver a long-awaited drug pricing strategy speech to put “America’s patients first.” While


Hospitals Face Sizable Overpayment Liability for Not Reporting Medical Device Credits
  • Nelson Mullins Riley & Scarborough LLP
  • USA
  • April 9 2018

The Office of Inspector General (OIG) continues to unearth widespread noncompliance by hospitals with requirements for reporting the receipt of


First-Of-Its-Kind Decision: Medicare Will Now Cover Certain Diagnostic Tests Utilizing Next Generation Sequencing for Cancer
  • Arent Fox LLP
  • USA
  • March 29 2018

As a result of the FDA-CMS Parallel Review Program, and representing a first-of-its-kind decision, the Centers for Medicare & Medicaid Services (CMS)


Drug Price Transparency Bill Enacted in Oregon
  • Cooley LLP
  • USA
  • March 14 2018

The Governor of Oregon signed into law this week House Bill 4005, the Prescription Drug Price Transparency Act (Act). The Act requires manufacturers