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FDA Doubles Down on Medical Device Program

USA - December 21 2018 FDA has been establishing policies to benefit new programs for the medical device industry, including opportunities in the Digital Health arena and…

Paul S. Gadiock, James R. Ravitz.

FDA Targets Sales of E-Cigarette Manufacturer Juul to Minors in Surprise Inspection

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…

Paul S. Gadiock, James R. Ravitz, Georgia C. Ravitz.

DEA Scheduling of Epidiolex Revealed

USA - October 1 2018 This decision follows the June 25 FDA approval of Epidiolex®, the first cannabis-derived drug, that we drafted an alert on here. Epidiolex is…

Paul S. Gadiock, Emily M. Leongini, James R. Ravitz.

FDA Issues Guidances for Shared REMS and Waivers to Help Promote Competition and Access

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…

California Court of Appeals Hears Hemp Industry Lawsuit Challenging DEA Code for 'Marihuana Extracts'

USA - March 26 2018 On February 15, 2018, the 9th Circuit Court of Appeals in San Francisco heard oral arguments regarding the Hemp Industry Association’s petition…

James R. Ravitz.