RGD: IND Exemption Criteria

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Summary

This checklist will assist investigators in determining if an IND is needed from the FDA in order to conduct a clinical trial using a drug or biologic.  The IRB may determine that an IND is not necessary based on the criteria below. However, the IRB may also require that the investigator request and exemption from the FDA, which requires the submission of an IND application.  

Related Glossary Items

• Food and Drug Administration (FDA)
• Biologic

Type of Document

• Guidance