22 Aug ValidCare Launches National Consumer Experience Program to Gather CBD Real World Evidence for FDA
New program and consumer application bring an industry-level approach to consumer data to address the FDA’s questions on the safety and efficacy of cannabis-derived products
Centennial, Colo. – August 22, 2019 – ValidCare, the market intelligence leader for the canna-based product industry, announced a first of its kind National Consumer Experience Program to gather Real World Evidence (RWE) on cannabis-derived products. The goal of the industry wide program is to facilitate and accelerate the collection of trusted consumer data to inform the U.S. Food and Drug Administration’s (FDA) pressing questions on the safety and efficacy of cannabis-derived products.
Recent comments from the FDA reinforce the need for this consumer RWE. According to Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner, “We recognize that there is significant public interest in these products, for therapeutic purposes and otherwise. At the same time, there are many unanswered questions about the science, safety, and quality of many of these products. As we approach these questions, we do so as a science-based regulatory agency committed to our mission of protecting and promoting public health.”1
ValidCare is opening its consumer experience platform for 60 days, from September 1 through October 31, 2019, to collect the detailed RWE. “The FDA has invited the industry to bring forward safety and efficacy data and is communicating a continued need for this type of data to support its science-based approach to regulations. Now is the time for the industry to capture credible information about the effects of CBD when used by specific populations and for specific purposes. We are happy make our platform available to industry and consumers allowing collection this critical information for FDA,” said Patrick McCarthy, CEO and Founder, ValidCare.
Consumers can participate in providing CBD Real World Evidence by downloading the free CBD+me™ app at CBDplusmeapp.com, then track their experiences with cannabis-derived products. Canna-based product companies can invite their consumers to download the app and include their experience data. Canna-based product suppliers will have access to RWE related to their products and consumers. RWE submitted by consumers will be shared with the FDA while protecting company-specific intellectual property and consumer identities.
The CBD+me platform is for anyone interested in sharing product experiences as they pursue their personal wellness goals. Consumers set up a profile and goals for themselves or their loved one(s), journal the products they’re using and record the effects. Much like popular fitness or weight loss app-based communities, CBD+me provides the opportunity for daily tracking and a cumulative timeline of effects: in this case, achieving goals set by the consumer. Consumers can also submit a report should they experience any adverse product events, which ValidCare will share with product suppliers and FDA. Community members will also have access to the latest CBD-related news and communications from CBD+me educators, product suppliers, and industry associations.
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ValidCare, LLC is the market intelligence platform for the cannabis-derived product industry, powered by real-time consumer experiences. Through the ValidCare community, participants including consumers, product suppliers, researchers, and providers, come together to study, educate, measure and document the consumer experience using canna-based products. ValidCare’s proprietary app (CBD+me™) supports ongoing two-way communication, combining self-reported consumer data with advanced machine learning to deliver aggregated insights that help improve product quality, consistency, effectiveness, and the adoption of industry standards.
For more information, visit www.validcare.com or call 844-825-4322.