4. File the Initial IND & Receive an IND Number

  1. The initial IND submission should be accompanied by a cover letter, a Form FDA 1571 (see instructions) and a Certification Form 3674.  All must be submitted in triplicate (an original and two photocopies):
    1. The IND Sponsor-Investigator completes, signs, and dates the Form FDA 1571.
    2. The IND Sponsor-Investigator assembles the signed submission and makes three photocopies and one .PDF of the original documents.
    3. For an initial submission, the IND Sponsor-Investigator sends the original and two photocopies to the following address via overnight courier.
      For a Drug: For a Therapeutic Biological Product:
      Food and Drug Administration
      Center for Drug Evaluation and Research
      Central Document Room
      5901-B Ammendale Rd.
      Beltsville, Md. 20705-1266
      Food and Drug Administration
      Center for Drug Evaluation and Research
      Therapeutic Biological Products Document Room
      5901-B Ammendale Road
      Beltsville, MD 20705-1266
  2. Keep a photocopy of the courier Airbill.  On the delivery date, track the shipment on the courier website for confirmation of delivery.  Print and file a copy of the delivery confirmation (select Adobe from the print menu).
  3. The IND Sponsor-Investigator files the .PDF and the third photocopy of the signed submission.  The IND Sponsor-Investigator’s photocopy 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.  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.