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Results: 1-10 of 1,343

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


Will Massachusetts be able to negotiate Medicaid prescription drug prices?
  • Gordon Rees Scully Mansukhani
  • USA
  • January 25 2018

In the absence of new federal policies to tame high price drugs, Massachusetts’ state Medicaid program is fighting for the power to negotiate


California Passes Two Drug Pricing Transparency Laws
  • Quarles & Brady LLP
  • USA
  • November 20 2017

Last month, California Governor Jerry Brown signed two new bills aimed at curtailing rising prescription drug costs, joining other states like


FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices
  • Reed Smith LLP
  • USA
  • November 15 2017

FDA recently released guidance ("Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request") finalizing its