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 If your research involves a new medical intervention, you'll need to obtain an investigational new drug (IND) or investigational device exemption (IDE) from FDA, unless FDA exempts your research.
This requirement applies to therapeutics, vaccines, and other medical interventions as well as licensed products and devices used for a new purpose. If you have any questions, contact your program officer early in
the process.
Before
award, provide your program officer with the name and institution of the IND or IDE sponsor, the date you filed with FDA, IND or IDE number, written comments from FDA, and written responses to
those comments. You should also include risk information from the investigator's brochure, a review of the published
literature, or other credible source.
You must notify NIAID if the FDA puts your study on clinical hold, and send in copies of all correspondence with FDA, including documentation that the hold has been lifted.
For intervention studies, you must obtain regulatory oversight by either FDA (under an IND or IDE) or the regulatory body of the country where the research is to be conducted. In the case of a foreign regulatory body, send NIAID written documentation from the regulatory body showing you are in compliance with local laws.
Additional Resources
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