FDA Teaches Marijuana Growers And Researchers How To Protect Trade Secrets From Competitors

The Food and Drug Administration (FDA) is hosting a meeting next week to help inform cannabis researchers and cultivators about opportunities to protect their proprietary information and promote studies into the plant. The webinar, which is taking place on Wednesday, will encourage cannabis-based drug developers and growers to use “drug master files,” or DMFs, which “are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.” In essence, a DMF is a secure method of transmitting private documents that could help supplement various proposals to the agency such as Investigational New Drug Applications (INDs) without risking competitors getting their hands on trade secrets. Participants in the event “will learn how DMFs might be able to help address their concerns related to the disclosure of potentially proprietary information,” FDA said in a notice. Further, the meeting will overview draft guidance FDA released in July that covers researching cannabis for drug development purposes. That document, which was released after being approved by the White House, explains the basics of conducting federally authorized research to create cannabinoid-based drugs such as where researchers are allowed to obtain marijuana and the importance of demonstrating the ability to “consistently manufacture a quality product.” FDA’s Cassandra Taylor from the Office of Pharmaceutical Quality will lead the meeting and also talk about the agency’s role in the “regulation of cannabis products.” “I think this sends the dual message that the FDA is…

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Source : MJ moment
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