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Results: 1-10 of 752

Life sciences: product regulation and liability in the USA
  • Perkins Coie LLP
  • USA, Global
  • October 11 2017

A structured guide to product regulation and liability in the USA


California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products
  • Cooley LLP
  • USA
  • September 18 2017

The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B


Health Hacking: Dealing with the cyber threat in digital health
  • Corrs Chambers Westgarth
  • Australia
  • September 1 2017

Software and the electronic devices it controls, has become increasingly important in the healthcare industry over recent years. 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


FDA Approves Final Label for Syndros
  • Knobbe Martens
  • USA
  • June 12 2017

On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros (dronabinol) oral solution, a Schedule II (CII


The Critical Role of Telemedicine in the Addiction Crisis
  • Cozen O'Connor
  • USA
  • February 17 2017

Telemedicine is now mainstream. Surprisingly, however, one area in which telemedicine has not been used to its fullest capability is drug addiction


Old Drug Label Still Requires Authentication of Publication Date
  • Jones Day
  • USA
  • February 17 2017

In IPR2016-01566 (Mylan Pharmaceuticals Inc. v. Boehringer Ingelheim International GMBH), the PTAB denied institution of an inter partes review of


FDA Hits “Pause” on Regulation of LDTs
  • Foley & Lardner LLP
  • USA
  • February 12 2017

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion


Recommended Reading: Advisory on the 21st Century Cures Act
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • December 21 2016

The 21st Century Cures Act (Cures Act) was signed into law on December 13, 2016, following a multi-year, bipartisan, and bicameral legislative effort


The 21st Century Cures Act
  • Arnold & Porter Kaye Scholer LLP
  • USA, United Kingdom
  • December 16 2016

Following a multi-year, bipartisan, and bicameral effort to accelerate the pace of the discovery, development, and delivery of new treatments