BRC Therapeutics (BRC), a clinical-stage pharmaceutical company developing multimodal cannabinoid therapeutics for neurological and inflammatory conditions, announced on Monday its participation in the Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development workshop, a joint session convened by the US 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.

BRC said that 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. According to BRC, these steps reflect regulatory momentum toward a clearer path for botanical medicines.

BRC has commenced multiple clinical trials for FDA-regulated, prescription-grade cannabinoid therapeutics targeting urgent unmet medical needs.