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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


In Rare Move, FDA Debars Company from Importing Food
  • Arent Fox LLP
  • USA
  • March 15 2018

For the first time in recent history, the Food and Drug Administration has debarred a foreign firm from importing food into the United States. The


FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer
  • Arent Fox LLP
  • USA
  • March 14 2018

On March 6, 2018, the US Food and Drug Administration issued an authorization letter to 23andMe, Inc. that permits marketing of the company’s genetic


Watchdog Groups Unleash New Wave of Proposition 65 Lawsuits Targeting Marijuana Dispensaries
  • Arent Fox LLP
  • USA
  • January 25 2018

As we reported in October 2017, marijuana dispensaries represent the latest wave of Proposition 65 targets. A new plaintiff is on a campaign against


FDA Ramps Up Transparency Initiative but Still Exploring Whether to Include CR Letters
  • Arent Fox LLP
  • USA
  • January 24 2018

On January 16, 2018, FDA Commissioner Scott Gottlieb, M.D., delivered a presentation, “Fostering Transparency to Improve Public Health” to the John


Biotech Policy Takes Shape: Rural Task Force Encourages Innovation and Regulatory Coordination
  • Arent Fox LLP
  • USA
  • January 22 2018

On January 8, 2018, the US Secretary of Agriculture, on behalf of the Interagency Task Force on Agriculture and Rural Prosperity, issued its


FDA Taps the Brakes on Certain Aspects of FSMA Compliance
  • Arent Fox LLP
  • USA
  • January 17 2018

Recently, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FDA Food Safety


OIG Report Highlights Impact of Improper Drug Classification
  • Arent Fox LLP
  • USA
  • January 12 2018

In late December 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released the findings of a report


What Could Happen to Imports If Government Shuts Down: 2017 Version
  • Arent Fox LLP
  • USA
  • December 15 2017

Based on recent activity in Congress, the possibility of a shutdown of US federal government activities for at least a brief period of time is looming


Rare Pediatric Disease Clinical Trials Get New Lift from EMA-Inspired Gaucher Model
  • Arent Fox LLP
  • USA
  • December 13 2017

On December 6, 2017, FDA announced a new approach for pediatric disease drug development that the Agency believes will reduce the number of patients