IND: Application Submission
Sponsor-Investigators: Investigators who hold their own IND assume all sponsor responsibilities required by the FDA, particularly record keeping and prompt reporting of safety reports to the FDA. The requirements of Sponsor-Investigators include both those of investigators and those of sponsors.
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 factor 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 acknowledgement 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 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 Office of Compliance 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 at (404) 727-2398 or email@example.com.