Review of FDA-Regulated Research Policy

Summary: This policy applies to how the Minimal Risk and Health Sciences IRBs apply US Food and Drug Administration (FDA) regulations to human subjects research.

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Applicable HRPP Policy

Attachments and Other References

Keywords:FDA, Biologic, Clinical investigation, Device, Drug, Human Subject, Off-Label, Significant risk device, Non-significant Risk Device, Test article, IND, Radioactive Materials, Radioactive Drug Research Committee, RDRC, radioactive, basic science research, biologics, devices, diagnostic device, consumer preference testing, In Vitro Diagnostic Devices, IVDs, IVD   Doc ID:58859
Owner:Monica E.Group:Health Sciences IRBs
Created:2015-12-10 13:36 CSTUpdated:2020-11-30 11:21 CST
Sites:Health Sciences IRBs
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