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Seeking Opinion from FDA Regarding Drug Exemption
Seeking FDA opinion on drug exemptions
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IU Human Research Protection Program (HRPP)
For research involving drugs, investigators should make an initial determination whether the use of the drug in the research requires an IND application, or whether the use may be exempt from the IND requirements. For more information about this determination, and how to request advice from the FDA regarding IND exemption, visit the FDA website on IND Application Procedures: Exemptions from IND Requirements.
Consider using the following template when seeking an opinion from the FDA regarding potential IND-exempt status:
FDA Opinion Letter (Accessible 07/03/19)
For further information regarding drug and device development, please contact the Indiana Clinical Translational Sciences Institute (CTSI) at: firstname.lastname@example.org.