U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
FDA eCTD Overview and Submission WBT
Transmitting Electronic Submissions to CDER
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Sending via Physical Media (cont.)

For a successful physical media submission, here are some recommended steps:

  1. Send submissions to the Central Document Room as an official submission for proper tracking and for security purposes; do not send via email.
  2. Submit a paper copy of the cover letter including the contact information and FDA form, in case the physical media proves to be unreadable.
  3. Send one copy of the electronic submission.
  4. Make sure to do a quality check of disks before submitting to avoid blank media.
  5. Do not send submissions directly to reviewers.
  6. For additional information, refer to Specification for Transmitting Electronic Submissions Using eCTD Specifications prior to submitting via physical media.
  7. Recognize that processing can take two to three days from submission receipt.
A cover letter with the FDA logo.
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