A recent spike in cannabis-related investigational new drug applications, along with the variety of potential cannabis ingredients, made a guidance on clinical studies necessary, said Norman Birenbaum, the US Food and Drug Administration's lead official for hemp and cannabis policy.
As Quantity Of Cannabis IND Applications Grows, US FDA Has ‘Quality Considerations’ Guidance
Research targeting botanicals generally, as well as cannabis, as potential APIs is increasing, a factor in CDER’s publication of cannabis trials guidance, the FDA’s Norman Birenbaum says in an interview.
