Skip to content
Product safetyFDAUnited StatesImports

Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information

6 October 2026

In plain English

FDA is opening a public docket for comments on its proposed design and safety approaches for early-phase clinical trials of ibogaine drug products, including HHS-funded studies in OUD and PTSD.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
6 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early- phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department of Health and Human Services (HHS) is funding clinical development of ibogaine, and the first federally supported trials are expected to study ibogaine in adults with opioid use disorder (OUD) and adults with post-traumatic stress disorder (PTSD). FDA is bu
The full text is at the source

Olive tells you which of these hit your products.

Olive reads every change like these against your own products, codes and trade lanes, whether you import, export or both, and drafts the update to your compliance program for your approval. Nothing changes without you.

Get startedLive demo

Olivra lists official notices for information only. It is not legal advice, and Olive is not a lawyer or a licensed customs broker. The official text at the source is what counts.

More from FDA

See everything Olive monitors