We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results:1-10 of 334

CMS considers linking Medicare drug payment rates to international prices
  • Hogan Lovells
  • USA
  • October 30 2018

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) describing a potential


Trump touts “historic” plan to overhaul Medicare payments, create International Pricing Index
  • Hogan Lovells
  • USA
  • October 25 2018

President Trump today touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed


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


FDA embraces real-world evidence in new final guidance
  • Hogan Lovells
  • USA
  • September 15 2017

On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support


FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information
  • Hogan Lovells
  • USA, European Union
  • August 25 2017

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission - DG Sante (DG Sante), signed a new


FDA Begins Reorganization that Will Affect How it Regulates Medical Technology
  • Hogan Lovells
  • USA
  • June 1 2017

The U.S. Food and Drug Administration (FDA) has undertaken significant reorganization efforts this year that affect the way it regulates medical


Measures of success: How value-based pricing may change the pharmaceutical industry
  • Hogan Lovells
  • USA
  • June 1 2017

Adoption of value-based pricing, where drug prices are linked to real-world outcomes rather than on a per-pill or per-treatment basis, will have a


“Double Dip” Effectively Approved by Center for Medicare and Medicaid Services
  • Hogan Lovells
  • USA
  • May 11 2017

Last week the Centers for Medicare and Medicaid Services (CMS) issued Release No. 104 to Manufacturers and Release No. 180, which invalidated earlier


What’s in store for the Affordable Care Act and drug pricing policy under the Trump administration?
  • Hogan Lovells
  • USA
  • February 27 2017

The Trump administration has been vocal in its criticism of the Affordable Care Act (ACA), and already has worked with the Republican-controlled


CMS Delays Addition of U.S. Territories to Medicaid Drug Rebate Program
  • Hogan Lovells
  • USA
  • November 15 2016

On 14 November 2016, the Centers for Medicare and Medicaid Services (CMS) released an interim final rule with comment period (IFR), effective 15