BRC Therapeutics Joins FDA and EMA Talks on Botanical Drug Standards

Dr. Catherine Maher, BRC’s Head of Regulatory Affairs, represented the Monterey-based firm at the invitation-only event. The workshop serves as a critical bridge between developers and global oversight bodies, aiming to establish a rigorous, science-driven framework for botanical therapies. This collaboration aligns with recent FDA initiatives, including a formal Request for Information launched earlier this month to gather industry input on accelerating the development of these products.

For BRC, the participation reinforces its current strategy of moving multimodal cannabinoid therapeutics through clinical trials. The company is currently testing treatments for Complex Regional Pain Syndrome and Aromatase Inhibitor-Induced Arthralgia. CEO George Hodgin noted that the coordination between the FDA and EMA is essential for creating a viable commercial environment for novel medicines that address currently unmet patient needs. By engaging directly in these discussions, BRC seeks to influence the regulatory landscape, ensuring that future patient access to safe, validated botanical therapies remains a priority.