File the IND

The initial IND submission should be accompanied by a cover letter, a Form FDA 1571, a Form FDA 1572, and a Form FDA 3674. All must be submitted in triplicate (an original and two photocopies):

For an initial submission, the IND Sponsor-Investigator sends the original and two photocopies to the following address via overnight courier:

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 Biologic:

Food and Drug Administration
Center for Drug Evaluation and Research
Therapeutic Biological Products Document
Room 5901-B Ammendale Road
Beltsville, MD 20705-1266

Important

Keep a copy of the entire IND submission.

Keep a photocopy of the courier air bill.

The FDA responds to the initial submission of a new IND with a letter, acknowledging receipt of the submission and assigning the IND number. An IND generally goes into effect 30 days after the date of receipt shown in this letter.

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