Determining Whether Human Research Studies Can Be Conducted Without an IND
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Food Safety and Applied Nutrition (CFSAN)
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators,2
and institutional review boards (IRBs) in determining whether research studies involving human
subjects must be conducted under an investigational new drug application (IND), as described in
title 21 of the Code of Federal Regulations, part 312 (21 CFR part 312) (the IND regulations).
This guidance describes when an IND is required, specific situations in which an IND is not
required, and a range of issues that, in FDA’s experience, have been the source of confusion or
misperceptions about the application of the IND regulations.
This guidance addresses only whether an IND is needed. If your study also involves the use of a device, you should determine whether such use is subject to 21 CFR part 812 (the IDE regulations). FDA's guidance documents, including this guidance, do not establish legally enforceable READ MORE