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Results: 1-10 of 1,632

A Petitioner’s Dilemma in Post-Grant Reviews
  • K&L Gates
  • USA
  • June 5 2018

Post-grant reviews ("PGRs") can only be filed within a nine-month window starting from the issuance of the patent, but standing to appeal to the


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


New CMS Guidance for ADLT Lab Tests and ADLT Application Released
  • Reed Smith LLP
  • USA
  • April 6 2018

CMS is still rolling out policies and procedures to fully implement the major clinical laboratory payment reforms mandated by the Protecting Access to


Federal Right To Try Legislation - Is It Any Better? - 2018 Edition
  • Reed Smith LLP
  • USA
  • March 23 2018

A little more than six months ago, we reviewed then-pending federal right-to-try legislation. Since then it’s become a shiny object, capable of


Connected medical device vulnerabilities continue to impact manufacturers, health care
  • Thompson Coburn LLP
  • USA
  • March 22 2018

Recently, Thompson Coburn’s Life Sciences Decoded blog described several FDA initiatives to increase the safety and reliability of the emerging


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


Efforts to Cut Drug Prices in Medicaid
  • Manatt Phelps & Phillips LLP
  • USA
  • February 27 2018

Over the past five years, the budgets of state Medicaid programs have been challenged by the introduction of new high-cost drugs into the marketplace


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


FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices
  • Reed Smith LLP
  • USA
  • January 16 2018

On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for


Breaking News: TH v. Novartis - California Supreme Court Recognizes New Tort Duties as Traditional Limits Slide into the Sea
  • Reed Smith LLP
  • USA
  • December 21 2017

We posted our 2017 "Worst 10 decisions" list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis