Submitting the Initial IND

IND Applications can be submitted electronically or by mail (hard copy). FDA prefers 12pt font, but smaller fonts will still be accepted. The font should be consistent throughout the entire submission. Use black typeface, with standard blue formatting for hyperlinks if included. Any pictures should be included/printed in color. The FDA requires that all electronic signatures are 21 CFR Part 11 compliant. When obtaining electronic signatures for FDA documents (e.g., Cover Letter, 1571, 1572), you must use UCSF's 21 CFR Part 11 compliant Docusign Module.

Electronic Submissions (recommended)

• CDER (Drugs) Research INDs: Research INDs (where the sponsor intends to conduct clinical research for publishing and general knowledge and does NOT intend to commercialize the product) reviewed by CDER can be submitted electronically through the CDER NextGen Portal (recommended).
• Commercial INDs or CBER (Biologics) Research INDs: Biologic research INDs and Commercial INDs, where the sponsor intends to conduct clinical research to support a future marketing application, must be submitted electronically in Common Technical Document format (eCTD) through the FDA Electronic Submissions Gateway (ESG) .
• Note research INDs are not required to be submitted in eCTD format and may be also submitted through ESG or on paper as described below. 

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 Drugs:

U.S. Food and Drug Administration,

Center for Drug Evaluation and Research,

Central Document Room,

5901-B Ammendale Rd.,

Beltsville, Md. 20705-1266

For Therapeutic Biological Products:

U.S. Food and Drug Administration,

Center for Biologics Evaluation and Research,

Document Control Center,

10903 New Hampshire Avenue,

Silver Spring, MD 20993-0002

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 the FDA should be sent (if mail submission)
• 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 time, the 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 IRB application.