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Results:1-10 of 154

FDA Targets Sales of E-Cigarette Manufacturer Juul to Minors in Surprise Inspection
  • Arent Fox LLP
  • USA
  • October 8 2018

According to reports, two FDA inspectors, at times joined by a third official, arrived the morning of September 24 to Juul’s San Francisco office and


FDA is Getting Ready for Its Close-up on Labels
  • Arent Fox LLP
  • USA
  • August 24 2018

Through a series of recent statements, FDA Commissioner Scott Gottlieb has signaled that the agency is prepared to assert its enforcement authority


USDA and FDA Initiate Processes to Revise Regulation of Agricultural Biotechnology
  • Arent Fox LLP
  • USA
  • July 13 2018

The United States Department of Agriculture and the Food and Drug Administration have recently initiated processes to evaluate and propose revisions


FDA Issues Guidances for Shared REMS and Waivers to Help Promote Competition and Access
  • Arent Fox LLP
  • USA
  • July 11 2018

On May 31, 2018, the FDA announced two new guidances designed to help generic drug manufacturers to obtain access to shared Risk Evaluation and


FDA’s Approval of First Cannabis-Derived Drug Breaks New Ground, Met with Mixed Reactions
  • Arent Fox LLP
  • USA
  • July 5 2018

Last week, the Food and Drug Administration approved the first cannabis-derived drug, Epidiolex, for the treatment of two rare forms of epilepsy


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