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FDA-Regulated Research
Last Updated 1 year 6 months ago
The Food and Drug Administration (FDA) oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations.
Resources to Assist with FDA-Regulated Research
FDA definitions, stages of drug development, and guidance on when an IND is needed.
Investigational devices (significant risk, non-significant risk) and humanitarian use devices.
Information on single subject INDs/IDEs, IRB concurrence, emergency exemption from prior IRB review.
Information about regulatory sponsors (and the difference between sponsors and funders).