IND
Also written as: IND — Investigational New Drug
A US FDA regulatory application that must be filed before a novel CRISPR-based therapeutic can be administered to human subjects in clinical trials.
Full Definition
An Investigational New Drug (IND) application is submitted to the US Food and Drug Administration (FDA) to obtain authorisation to begin clinical trials of an unapproved drug or biologic, including CRISPR-based gene therapies. The IND contains preclinical data, manufacturing information, and proposed clinical protocols. In CRISPR therapy documents, editors will encounter 'IND' in regulatory filings, clinical study reports, and investor communications. It should always be abbreviated as 'IND' after the full form is introduced. The equivalent European pathway involves a Clinical Trial Authorisation (CTA).
Usage
Usage note: Always define at first use: 'Investigational New Drug (IND) application'. In gene-therapy manuscripts, distinguish from BLA (Biologics License Application) and NDA (New Drug Application), which are post-approval filings.
In Context
- "The company submitted an IND to the FDA in advance of its Phase I CRISPR trial for sickle cell disease." — Regulatory document summary
- "Preclinical safety data included in the IND demonstrated no detectable off-target editing at top-ranked sites." — Clinical study report