Company Applauds FDA and EMA Leadership as Regulators Prioritize a Clear Pathway for Botanical Medicines to Reach Patients
MONTEREY, Calif. (September 28, 2026). BRC Therapeutics (BRC), a clinical-stage pharmaceutical company developing multimodal cannabinoid therapeutics for neurological and inflammatory conditions, today announced its participation in the Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development workshop, a joint session convened by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in Amsterdam, the Netherlands. Dr. Catherine Maher, BRC’s Head of Regulatory Affairs, represented the company at the workshop, which brought together regulators and drug developers to discuss regulatory considerations for botanical drug products intended for medicinal use. In person participation was limited and BRC received an invitation to attend.
The workshop follows a period of accelerating momentum for botanical drug development at the FDA. Earlier this month, the agency announced a formal Request for Information seeking public and industry input on opportunities to advance botanical drug products, and BRC submitted a contribution to the docket. The workshop also builds on an invitation-only botanical drug development roundtable that the FDA’s Center for Drug Evaluation and Research convened with the Reagan-Udall Foundation for the FDA. Taken together, these steps reflect real regulatory momentum toward a clearer path for botanical medicines, an area where BRC has put a stake in the ground. BRC has commenced multiple clinical trials for FDA-regulated, prescription-grade cannabinoid therapeutics filling urgent unmet medical needs.
“BRC applauds the FDA and EMA for their leadership and collaboration on display this week,” said George Hodgin, Founder and CEO of BRC Therapeutics. “The botanical drug development pathway in the U.S. has the potential to create novel pharmaceutical products that serve patients with needs not met by current therapeutics. Seeing two of the world’s leading regulators sit down together to support pharmaceutical developers who are navigating a complex path based on science is the kind of prioritization this field needs. We are more excited than ever to continue developing important medicines for the patients who need them most.”
“It was energizing to be in the room as FDA and EMA worked together to support botanical drug development,” said Dr. Catherine Maher. “Public interest in the therapeutic potential of botanical drug products is growing rapidly. Being part of these discussions at the EMA allows us to help shape a more predictable, scientific approach to review and development, ultimately accelerating patient access to safe, validated therapies. These conversations move the field forward, and BRC is glad to be part of them as we advance our own pipeline.”
BRC continues to advance its pipeline and looks forward to further engagement with the FDA and EMA as the agencies shape the future of botanical drug regulation.
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BRC Therapeutics (BRC) is a clinical-stage drug development company focused on advancing innovative therapeutics for CNS conditions. BRC’s medicines are multimodal and contain cannabinoids at defined ratios. BRC has developed a pipeline of investigational prescription medicines addressing neurological and inflammatory conditions with two currently being tested in clinical trials for Complex Regional Pain Syndrome (CRPS), and Aromatase Inhibitor-Induced Arthralgia (AIIA). BRC is registered with the Drug Enforcement Administration and is based in Monterey, CA.
To learn more about BRC, visit https://brctherapeutics.com/.
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