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Keeping you afloat amidst the rising sea of regulations

California State and Local Cannabis Rules Take Different Paths

Over the past month, California has been a veritable hotbed of activity regarding the regulation of cannabis for both medical and adult use. Most notably, on June 27, Governor Jerry Brown signed into law the Medicinal and Adult-Use Cannabis Regulation and Safety Act to harmonize and reconcile the state’s requirements for medical and adult use, which previously imposed different standards based on the cannabis’ use.

FDA and Duke University to Explore Expanded Use of Real-World Evidence for Drugs in Public Workshop

On September 13, 2017, FDA and the Duke-Robert J. Margolis, MD Center for Health Policy will bring stakeholders to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and decision making. Topics in general will include an update on FDA’s activities to address the use of RWE in regulatory decision and development of a framework for handling challenges related to accepting RWE. Panelists are expected to discuss opportunities to improve data development activities, study designs, and analytical data to create robust RWE.