Halloran's View On FDA's Draft Guidance On Psychedelic Drugs

By Yolande Haydon

The U.S. Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Psychedelic Drugs: Considerations for Clinical Investigations." This guidance, as emphasized by the FDA, aims to promote ethical trial practices, maintain trial integrity, and secure the reliability of trial outcomes.

For Halloran, several questions arise:

1. What necessitates the creation of this guidance?
2. How does this guidance align with other drug development-related guidelines?
3. What aspects of this guidance specifically pertain to psychedelic substances?
4. What areas should the FDA reevaluate before finalizing this guidance, according to Halloran's perspective?

Read the full article below to explore these questions and how interdisciplinary teams can be supported in the nascent field of psychedelic therapeutics.