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.

The FDA is trying to create standards for safe use of hemp and cannabis-related ingredients while still maintaining access to the products. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock, FDA images

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.

“Guidance aside, over the last 50 years we’ve seen more than 800 investigational new drug applications, but half of those...