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Results: 1-10 of 764

Materiality Part II: Government Knowledge
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • January 3 2018

This is the second in a five-part series on how U.S. district courts and courts of appeal have applied the materiality standard set forth in Universal


OIG Report Assesses Accuracy of Manufacturer-Reported Medicaid Rebate Program Data
  • Reed Smith LLP
  • USA
  • December 21 2017

The OIG recently issued a report evaluating the accuracy of pharmaceutical manufacturer-reported Medicaid drug rebate program data, including pricing


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


OIG Wants CMS to Track Medicare Costs from Device Failures
  • Reed Smith LLP
  • USA
  • October 27 2017

A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates


CNN Investigates Expanding Use of Nuedexta in Nursing Homes
  • Stark & Stark
  • USA
  • October 16 2017

A recent investigation by CNN brought to light the expanding and allegedly inappropriate use of the prescription drug Nuedexta in nursing homes


FDA Makes Moves to Advance Digital Health
  • Epstein Becker Green
  • USA
  • August 17 2017

At the end of July, FDA released a tangible plan for promoting innovation in the development of digital health products. In this Digital Health


The Past, Present, and Future of Government Regulation of Off-Label Communications - Part 4
  • Mintz Levin
  • USA
  • August 14 2017

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent


OIG Targets Additional MedicareMedicaid Policy Areas for Review
  • Reed Smith LLP
  • USA
  • June 15 2017

The OIG has added 18 reviews to its FY 2017 Work Plan - most of which target CMS programs, with a particular emphasis on prescription drug policies


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


China's FDA Proposes Patent Linkage Mechanism and Terms for Data Exclusivity for Public Comments
  • LexField Law Offices
  • China
  • May 18 2017

The China Food and Drug Administration on May 12 proposed for the public's comments a draft regulation entitled Relevant Policies for Encouraging