Submitting the Initial IND

IND Applications can be submitted via hard copy (paper) submission or via electronic submission.

Hard Copy Submissions

• For an initial submission, the IND Sponsor-Investigator sends the original and two photocopies to the appropriate address via overnight courier.
• Keep one copy of the submission packet as well as a photocopy of the courier airbill.
• On the delivery date, track the shipment on the courier website for confirmation of delivery.  Print the delivery confirmation and file it with the PDF and third copy of the submission packet, which is kept in an IND study binder.

For a Drug:

U.S. Food and Drug Administration,

Center for Drug Evaluation and Research,

Central Document Room,

5901-B Ammendale Rd.,

Beltsville, Md. 20705-1266

For a Therapeutic Biological Product:

U.S. Food and Drug Administration,

Center for Biologics Evaluation and Research,

Document Control Center,

10903 New Hampshire Avenue,

Silver Spring, MD 20993-0002

Electronic Submissions

This content is currently under development. 

The FDA reviewing division responds to the IND submission with a letter acknowledging receipt that includes:

• IND number assigned
• Date of receipt of the original/initial IND application
• Address where future submissions to FDA should be sent
• Name and telephone number of the FDA person to whom questions about the application should be directed

The Sponsor-Investigator must wait 30 calendar days before initiating any clinical trials.

• During this tie, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
• If there are no issues and the FDA does not place the trial on a clinical hold, the IND generally goes into effect 30 days after the date of receipt shown in the FDA acknowledgment letter. 

It is best practice to obtain a Study May Proceed Letter from the FDA and to upload the letter under the "Other Study Documents" section of your application in iRIS.