File the Initial IND and Receive Your IND Number

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All forms completed during  Initial IND Submission Preparation must be assembled into one submission packet. The forms are submitted in triplicate (the original and two photocopies).

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.

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

On the delivery date, track the shipment on the courier website for confirmation of delivery.  Print the delivery confirmation (select Adobe from the print menu) and file it with the PDF and third copy of the submission packet, which is kept in an IND Binder.

The FDA responds to the initial submission of a new IND with a letter, acknowledging receipt of the submission and assigning the IND number. The sponsor must wait 30 calendar days before initiating any clinical trials.  During this time, 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, the IND generally goes into effect 30 days after the Date of Receipt shown in this letter. It is advised that you obtain written confirmation (email or fax) that the FDA review has been completed and that the Study May Proceed. Please upload FDA Study May Proceed confirmation in iRIS under other study documents.

The IND Acknowledgement letter also provides the mailing address for all subsequent submissions to the IND.

Need assistance or have regulatory questions? Please contact CTSI Consultation Services