Regulatory & Documentation
IND Application (Investigational New Drug)
An Investigational New Drug (IND) application is the submission a sponsor files with the FDA to obtain authorization to ship an unapproved drug across state lines and to administer it to humans in a clinical trial.
An IND has three principal sections: chemistry, manufacturing, and controls (CMC); pharmacology and toxicology; and clinical (the protocol, IB, investigator information, and informed-consent process). FDA has 30 calendar days to place the IND on clinical hold; if no hold is issued, the sponsor may proceed.
The IND remains active throughout development; protocol amendments, annual reports (DSURs), and safety reports (IND Safety Reports) are filed as supplements. Comparable submissions in other regions include the Clinical Trial Application (CTA) in the EU under CTR 536/2014 and CTAs in Health Canada, MHRA, PMDA, etc.
Related terms
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
Investigator Brochure (IB)
An Investigator's Brochure (IB) is the comprehensive document, updated at least annually, that summarizes all available clinical and non-clinical data on an investigational product, allowing investigators to assess the benefit-risk balance for trial participants.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical and scientific quality standard, codified in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human participants.
See how Kitsa applies this in your trials
Kitsa's agentic AI compresses protocol development, site selection, and patient pre-screening from months into weeks.
Request a demo