U.S. Food and Drug Administration
Protecting and Promoting Your Health
Sending via Physical Media (cont.)
For a successful physical media submission, here are some recommended steps:
- Send submissions to the Central Document Room as an official submission for proper tracking and for security purposes; do not send via email.
- Submit a paper copy of the cover letter including the contact information and FDA form, in case the physical media proves to be unreadable.
- Send one copy of the electronic submission.
- Make sure to do a quality check of disks before submitting to avoid blank media.
- Do not send submissions directly to reviewers.
- For additional information, refer to Specification for Transmitting Electronic Submissions Using eCTD Specifications prior to submitting via physical media.
- Recognize that processing can take two to three days from submission receipt.
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