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
Sending via Physical Media

You can also send your submission via physical media if it is greater than 10 GB. Only one electronic copy is required and it is recommended that you submit a paper copy of the cover letter including the contact information and FDA form, in case the media proves to be unreadable.

For more information on transmitting via physical media, refer to the transmission specification document, which is located under the Resources tab.

The link to the transmission specification is located in the eCTD Submission Standards (under Quick Links on www.fda.gov/ectd).

A blank DVD and a blank CD. Below the photo is the text: IMPORTANT: Do not compress data.
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