File the Initial IND and Receive an IND Number
- The initial IND submission should be accompanied by a cover letter, a Form FDA 1571 (see instructions) and a ClinicalTrials.Gov Certification of Compliance - FDA 3674. (All forms optimized for Safari)
- All must be submitted in triplicate (an original and two photocopies):
- The IND Sponsor-Investigator completes, signs, and dates the Form FDA 1571.
- The IND Sponsor-Investigator assembles the signed submission and makes three photocopies and one PDF of the original documents.
*Please Note: Academic Institutions are not required to submit electronically. However, if you would like to submit electronically, please see the following contacts and guidance.
- Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at esub@fda.hhs.gov or CBER at esubprep@cber.fda.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.
- Please visit the Electronic Common Technical Document (eCTD) web page to access a wide variety of resources and support regarding eCTD 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.
For a Drug:
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:
Food and Drug Administration
Center for Drug Evaluation and Research
Therapeutic Biological Products Document Room
5901-B Ammendale Rd.
Beltsville, MD. 20705-1266
On the delivery date, track the shipment on the courier website for confirmation of delivery. Print the delivery confirmation and file it with the 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 WebIRB 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 the CTSI Office of FDA Affairs.