Investigational drugs
What is an Investigational New Drug application and who has to file one?
Plain English first, then the primary source. Education, not legal advice.
Interpretation
In short: studying an unapproved drug in people generally requires an authorized pathway before the first subject, not after.
Plain English
An IND, governed by 21 CFR Part 312, is the mechanism by which a sponsor obtains permission to ship an unapproved drug across state lines for the purpose of conducting a clinical investigation in humans. Without an effective IND, or an applicable exemption, shipping an investigational drug for human clinical study is generally prohibited.
The IND process requires preclinical data, a detailed protocol, investigator information, and manufacturing information, and it is reviewed by FDA before human dosing can begin.
A researcher who has an idea, an RUO chemical, and willing participants does not have a legal pathway to human testing without going through this process or qualifying for a narrow exemption.
Why it matters
- This directly addresses the gap between 'I can buy the compound' and 'I can legally give it to a person as part of a study.'
Where the answer becomes fact-specific
The Foundation does not manufacture legal conclusions. These points change the analysis and may require qualified regulatory counsel.
- Whether an activity counts as a 'clinical investigation' requiring an IND depends on the specific protocol, the number of participants, and how data will be used or reported.