Docket Number:
FDA-2008-D-0406
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biological products. This guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application (IND) regulations) and describes how to complete the Statement of Investigator (Form FDA 1572).

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0406.