The Food and Drug Administration (FDA) has opened a new public docket seeking input on how the federal government can improve and accelerate the development of botanical drug products, a process that also applies to medicines derived from cannabis.
The FDA announced the request for information September 3, saying it wants feedback on challenges facing botanical drug research and potential ways to modernize the regulatory process.
Botanical drugs include products made from or derived from plant materials that are intended to diagnose, cure, mitigate, treat or prevent disease. Although the new request does not specifically mention marijuana or cannabis, FDA guidance explicitly identifies cannabis-derived drugs as products that may fall under its botanical drug framework.
The agency says researchers developing cannabis-derived medicines, including those containing cannabidiol (CBD), are encouraged to work with its Center for Drug Evaluation and Research and Botanical Review Team.
In a separate cannabis-specific guidance, the FDA notes that cannabis and cannabis-derived compounds used in human medicines can include botanical raw materials, extracts and highly purified substances of botanical origin.
The new docket seeks input on challenges encountered during botanical research and drug development, innovative approaches that could accelerate development, potential updates to FDA guidance and resources, quality standards and appropriate study designs for complex botanical mixtures.
The agency is also asking about the potential use of real-world evidence and other scientifically credible information to support botanical drug development.
The FDA said botanical products can present unique regulatory challenges because of their complexity and variability. To date, four botanical products have been approved as prescription drugs through the agency’s new drug application or biologics license application pathways.
The docket is listed as FDA-2026-N-9550 under the title “Advancing Development of Botanical Drug Products; Request for Information.”
Comments will be accepted through November 3.
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