U.S. Food and Drug Administration
Protecting and Promoting Your Health
The FDA offers assistance to small businesses that plan to provide a submission using the eCTD specifications. The FDA recommends that you follow these steps to help smooth the process:
- Review the published guidance and specifications documents provided on the eCTD Web site, located under the Resources tab.
- Submit an eCTD sample prior to submitting an actual eCTD submission.
- Refer to the Comprehensive Table of Contents Headings and Hierarchy on the eCTD Web site, a link to which is located under the Resources tab.
Let's look at each of these steps in more detail.
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