The Food and Drug Administration recently offered a glimpse into its comprehensive analysis justifying its recommendation to reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act.
CDER director Patrizia Cavazzoni explained that as part of the FDA’s “directive to explore whether marijuana should remain listed as Schedule 1 under the Controlled Substances Act,” the FDA conducted “an expansive review of numerous data sources.”
The 2023 fiscal year Drug Safety Priorities report reveals a multi-pronged approach employed by the FDA’s Center for Drug Evaluation and Research (CDER). At the core was an eight-factor analysis (8FA) drawing upon “numerous data sources,” as stated in the report, noted Marijuana …