Drug Studies

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. This authorization must be secured prior to administration of any new drug, biological product that is not the subject of an approved New Drug Application, or Biologics/Product License Application. An IND may be required for a clinical investigation using a marketed drug for a use other than the indications in the approved labeling. FDA provides this guidance for Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.

IND Support

The Office of Compliance can assist investigators, coordinators and the Emory research community in determining which regulations apply to the research along with providing education and consultation regarding regulatory requirements, compliance obligations and best practices for Sponsor Investigators.  Please contact us at (404) 727-2398 or compliance@emory.edu for assistance with determination of IND requirements, submission of the IND application, or maintenance of the IND.

Guidance for Emory Sponsors and Sponsor-Investigators includes information on IRB submission of S-I studies including Continuing Review and amendments.  When the IRB identifies a study as one having an Emory investigator as S-I, the S-I will be referred to the Office of Compliance for training about specific S-I responsibilities.  The S-I will be requested to complete the appropriate Emory S-I IND Responsibility Forms.

The Office of Compliance provides one-on-one consultations regarding the following topics:

If you have questions or would like to discuss topics related to investigator-initiated research, please contact us at (404) 727-2398 or compliance@emory.edu.