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Results:1-10 of 587

Recycle, Recycle, Recycle: Key Considerations for Research, Medical Education, and Other Secondary Uses of Data
  • McDermott Will & Emery
  • USA
  • June 6 2018

The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with


Health Apps: Convenience vs. Security Risks
  • Jackson Lewis PC
  • USA
  • May 9 2018

The pace of innovation in healthcare today has produced an amazing increase in the number of available mobile apps for health-related information


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


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


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