21 CFR 312.23 - IND Content and Format

What it says

An IND must contain a cover sheet, a table of contents, an introductory statement and general investigational plan, an investigator's brochure, clinical protocols, chemistry, manufacturing and control information, pharmacology and toxicology information, a summary of previous human experience with the drug, and any additional information relevant to the safety or conduct of the proposed investigation. Information must be organized and submitted in the format FDA specifies.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Chemistry, manufacturing and control information is a significant part of the IND, and the amount of detail depends on the phase of the investigation.
• Nonclinical data in the IND must support the proposed clinical dose and duration.
• Amendments keep the IND current as the program develops.

What FDA inspectors look for

• Whether information in the IND matches how the study is actually conducted.
• Whether manufacturing of investigational product follows the CMC description.
• Whether required amendments were submitted.

Related regulations