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, a 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.

The Office of Research Integrity and Compliance (ORIC) 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 ORIC Emory for assistance with the determination of IND requirements, submission of the IND application, or maintenance of the IND.

The Emory IRB website page on 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 Checklist.

IND regulations are contained in Title 21, Code of Federal Regulations, Part 312.

An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved new drug application.

"Investigational new drug" or "investigational drug" includes (i) an unapproved drug, or (ii) an approved drug being studied, in a formal research study, for a new indication, route of administration, dosage level, subject population, or other factors that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the product.

Upon receipt of the IND submission by the FDA, the investigator may proceed with the clinical study 30 days after the receipt date on the FDA's IND acknowledgment letter (unless notified by FDA not to begin the study) OR on receipt of an IND 'may proceed' letter from FDA. If no correspondence is received from the FDA, it's a good idea to follow up in order to obtain written confirmation that the investigation 'may proceed'.

The IND Application Submission Checklist (DOCX) is a tool investigators can use to determine what items are needed when preparing an IND submission to the FDA. While the checklist itself should not be submitted, it provides a list of items needed and includes links to various document templates.

This FDA table, Investigator-Initiated Investigational New Drug (IND) Applications, provides links to information for investigators about submitting Investigational New Drug (IND) applications to FDA.

The ORIC staff is available to assist with IND submissions. If you would like assistance, have questions, or would like to discuss topics related to investigator-initiated research, please contact us.

Once an IND application is in effect, the sponsor of the application may amend the application as needed to ensure that the clinical investigations are conducted according to protocols included in the IND application.

A sponsor of an IND application is expected to submit a protocol amendment when:

  • There is a new study using the same drug/biologic which is not covered by the current protocol. Such amendment should contain a brief description of the most clinically significant differences between the new protocol and the previous protocols and should be identified on Form FDA 1571 as: "Protocol Amendment: New Protocol"

  • There are changes in the existing protocol that significantly affect the safety of subjects, the scope of the investigation, or the scientific quality of the study. Such amendment should contain a brief description of the change and reference (date and number) to the submission that contained the original protocol. Changes to the existing protocol(s) should be identified on Form FDA 1571 as: "Protocol Amendment: Change in Protocol"

  • There is a new investigator. A sponsor of an IND application is expected to submit a protocol amendment when a new investigator (PI) is added to carry out a previously submitted protocol. The amendment should include the investigator's name, the qualifications to conduct the investigation (CV and medical license, if relevant), and signed Form FDA 1572. FDA should be notified within 30 days of the investigator being added. The addition of a new investigator should be identified on Form FDA 1571 as: "Protocol Amendment: New Investigator"

Sponsors are expected to submit protocol amendments for new protocols or significant changes to existing protocols before implementation of the respective changes. New studies may begin when the sponsor has submitted the change to FDA for its review and the new protocol or changes to the existing protocol have been approved by the Institutional Review Board (IRB) with the responsibility for review and approval of the studies. If the IND application sponsor desires FDA to comment on a submission, they should submit a request for such comment and the specific questions that FDA's response should address.

When several submissions with minor amendments are expected within a short period, sponsors are encouraged, to the extent feasible, to include all amendments in a single submission.

To assist with the IND Amendment submission process to add a new protocol, please click the links below:

ORIC one-on-one consultations regarding the following topics:


Contact us

If you have questions or would like to discuss topics related to investigator-initiated research, please contact us at ORIC Emory.