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FDA issues clinical research guidance for cannabis

Unraveling the FDA's New Cannabis Research Guidelines

FDA issues clinical research guidance for cannabis January 24, 2023January 24, 2023 Cannabis Daily News 3 mins read CANNABIS RESEARCH FDA issues clinical research guidance for cannabis Benzinga reports that The FDA has now issued final guidance outlining its stand on topics relevant to scientists related to the development of human medicinal products containing cannabis or cannabis-derived compounds. The guidance recommends: Sources of cannabis. Resources for information on quality considerations. Considerations of Control Status under the CSA. The FDA has also provided recommendations for sponsors interested in developing such cannabis and cannabis-derived compounds for use in human drugs for clinical research. ADEUS PORTUGAL Clever Leaves leaving Portugal as they let go of 21% of staff MJ Biz Daily reports that Clever Leaves Holdings plans to cut almost one-quarter of its total workforce and wind-down operations in Portugal as part of a major restructuring effort. The move is expected to result in USD$7 million in annualised savings. MJ Biz Daily highlights that Clever Leaves estimates the plan will cost up to $21 million, including: Up to $7 million in written-off inventories. $12 million-$13 million in real estate and equipment exit costs. Almost $1 million related to severance and employee benefits. According to the company’s statement in a U.S. Securities and Exchange Commission filing: “These savings will partially mitigate the impact of higher labour costs and headwinds from the macroeconomic environment, as well as fund additional investments to continue to drive a more efficient cost structure long term.” DRAFT LAWS Germany looks to placate brussels as its cannabis plans teeter Delays in submitting its proposals to the European Commission and potential hold-ups once submitted could see Germany’s adult-use cannabis plans pushed back into 2025, writes BusinessCann. Germany’s draft cannabis law will not now be submitted for Europe’s approval until the end of March. In a statement to BusinessCann The German Federal Ministry of Health confirmed the draft law is currently ‘being formulated within the federal government’ and said it is also seeking ‘expert opinion to shed light on the effects of a controlled sale of cannabis on health and youth protection and consumption’. It is also undertaking ‘a systematic review of the literature’ pertaining to those countries who have some form of legalised recreational cannabis, and, in a statement to BusinessCann the Home Affairs Directorate of the European Commission reiterated that personal drug consumption was a matter for nation states.

The U.S. Food and Drug Administration (FDA) has issued clinical research guidelines for cannabis, prompting a significant impact on the medical and legal cannabis sectors. The guidelines highlight the measures to be respected for scientific research and the steps for cannabis-based drug approval. This blog post aims to shed some light on these guidelines and their implications for clinical research.

The FDA's new guidelines represent a positive step toward acknowledging cannabis's potential medical applications. They have laid down specifics on the kinds of cannabis research to be conducted, the quality control measures that labs need to implement, and the submission process for Investigational New Drug (IND) applications.

In conclusion, the FDA's issuance of clinical research guidelines for cannabis represents a landmark moment in the normalization and legalization of medical cannabis. It not only elevates the legitimacy of cannabis research but also provides a clear path for scientists and researchers interested in delving into this potent plant's possible benefits.

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