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Additional Discovery of Clinical Trial Data in Inter Partes Review
  • Baker & Hostetler LLP
  • USA
  • March 30 2018

In Apotex, Inc. et al. v. Novartis AG (IPR 2017-00854, paper 47 dated Feb. 5, 2018), petitioner Apotex sought, and was granted, discovery of a Phase


Oregon Joins Growing Number of States with New Drug Pricing Transparency Laws
  • Arent Fox LLP
  • USA
  • March 21 2018

Oregon is the latest state to adopt a drug pricing transparency law, following in the footsteps of Vermont, California, Nevada, and Maryland, which


FDA Issues Final Rule on Acceptance of Data from Clinical Investigations
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 1 2018

Five years ago, in February 2013, FDA issued a proposed rule to revise the regulations under which FDA will accept data from clinical studies as


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 Cohn Ferris Glovsky and Popeo PC
  • 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