OFFICE OF THE VICE PRESIDENT FOR Research and Innovation

Contact usEventsFormsPoliciesGiveRAMS Systems

How to submit to the FDA

INDs submitted to Center for Drug Evaluation and Research (CDER)

Options include:

  1. Mail to CDER (Currently not being accepted by CDER):
    • Mail application in triplicates (one original and two copies) or an e-copy (CD, flash drive, etc.) plus a paper, signed cover letter to:
      • Food and Drug Administration
        Center for Drug Evaluation and Research
        Central Document Room
        5901-B Ammendale Rd.
        Beltsville, Md. 20705-1266
  2. Submit through CDER NextGen Portal
    • Everything submitted through this portal must be in a PDF format for it to be accepted.  When it has successfully been submitted, you will receive a confirmation email.  This confirmation email doesn’t mean that your submission has been reviewed and is safe to proceed; it just means that your submission has been received by CDER.
    • Reference guide to create an account and logging into to CDER NextGen Portal
    • FAQs for CDER NextGen Portal
  3. FDA Electronic Submissions Gateway (please see below on instructions how to use)

INDs submitted to Center for Biologics Evaluation and Research (CBER)

Options include:

  1. Mail to CBER (Currently not being accepted by CBER):
    • Mail application in as paper (one complete copy) or an e-copy plus a paper, signed cover letter (CD, flash drive, etc.) to:
      • Food and Drug Administration
        Center for Drug Evaluation and Research
        Therapeutic Biological Products Document Room
        5901-B Ammendale Road
        Beltsville, MD 20705-1266
  2. Email submission to CBER
  3. FDA Electronic Submissions Gateway (please see below on instructions how to use)

IDEs submitted to Center for Devices and Radiological Health (CDRH)

Options include:

  1. Mail to CDRH (Currently not being accepted by CDRH): 
    • Mail application as an e-copy (CD, flash drive, etc.) and a paper, signed cover letter to:
      • U.S. Food and Drug Administration
        Center for Devices and Radiological Health
        Document Control Center (DCC) – WO66-G609
        10903 New Hampshire Avenue
        Silver Spring, MD 20993-0002
    • Please follow the below guidance to make a proper e-copy for CDRH:
  2. Submit through CDRH’s Portal.  
    • Everything submitted through this portal must be in a PDF format.
    • Submit an eCopy not an eSTAR.

FDA Electronic Submission Gateway (ESG)

  1. Contact email for ESG related questions
  2. FDA’s Electronic Submissions Gateway webpage (includes links to WebTrader, WebTrader Test, Submit ESG Ticket, ESG UserGuide)
  3. Tipsheet: Setting up a WebTrader account with the FDA ESG
    Tipsheet: Submitting non-eCTD research INDs through the ESG
  4. Work instructions: Electronic submissions for Non-eCTD research INDs

NOTE: If you plan on using ESG as your submission method of choice, please be aware that it takes almost 2 full weeks to create an account and submit the test submission.  VCU would advise setting this up ahead of time before an IND submission needs to be submitted.

Single Patient INDs submitted to CDER, CBER or CDRH (Alternative to the above options)

  • Reagan-Udall Foundation (RUF) - An alternative submission process for single patient IND initial and follow up submissions. This website should not be used for emergency use IND requests. If the IND is submitted through RUF, it should not be submitted through the FDA normal submission channels (ex: CDER NextGen Portal).