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APHIS Changes Import Permit Policy for Medical Devices Containing Animal Derived Ingredients
  • Arent Fox LLP
  • USA
  • June 13 2018

Medical devices containing animal derived ingredients that have been approved by the Food and Drug Administration now may enter the US without the


Connecticut and Maine Become the Latest States to Adopt New Drug Pricing Transparency Laws
  • Arent Fox LLP
  • USA
  • June 6 2018

Connecticut and Maine recently joined the increasing number of states to enact drug price transparency laws. Maine’s drug price transparency law (the


FDA Proposes New Class II Device Marketing Pathway
  • Arent Fox LLP
  • USA
  • April 17 2018

The Expanded Abbreviated 510(k) Program could offer a quicker path to market for class II devices, with the potential for clearance decisions to


First-Of-Its-Kind Decision: Medicare Will Now Cover Certain Diagnostic Tests Utilizing Next Generation Sequencing for Cancer
  • Arent Fox LLP
  • USA
  • March 29 2018

As a result of the FDA-CMS Parallel Review Program, and representing a first-of-its-kind decision, the Centers for Medicare & Medicaid Services (CMS


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