FDA Regulated Studies

The Food and Drug Administration (FDA) is a federal agency which is responsible for protecting the public health by assuring that human drugs, vaccines and other biological products and medical devices intended for human use are safe and effective. Research studies which are regulated by the FDA must be conducted under the Code of Federal Regulations (CFR) Title 21.

Investigators who function as the Principal Investigator (PI) of a given study and who hold an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) are considered to be a Sponsor Investigator (S-I). The S-I is held accountable for all the roles and responsibilities under FDA regulations for an investigator and sponsor.

The Office of Research Integrity and Compliance (ORIC) provides education and compliance consultation in order to assure that investigations conform to applicable regulations. ORIC serves as a resource for investigators subject to inspections/audits by the Food and Drug Administration (FDA). If you have been contacted by the FDA regarding an inspection/audit, please contact us at ORIC Emory.

For more information and specific resources for conducting studies using drugs, devices or dietary supplements go to the specific tabs on the left navigational menu.

For more information on FDA inspection preparation, go to the FDA Inspections page.

If you have questions or would like to discuss topics related to FDA regulated studies, please contact us at ORIC Emory