// Definition
The regulatory pathway through the FDA for developing cannabis into an approved pharmaceutical drug, requiring proof of safety and efficacy through phased clinical trials.
// From the Episode
Rick Doblin explained how the FDA pathway requires developing the plant into an approved drug through phase 2 and phase 3 studies. He noted the FDA doesn't require knowing every active compound — just proving safety and efficacy. CMCR (Center for Medicinal Cannabis Research) had done phase 2 studies but nothing was followed up to phase 3. The key barrier was not FDA itself but NIDA's supply monopoly and DEA obstruction.