Important Notice: Our web hosting provider recently started charging us for additional visits, which was unexpected. In response, we're seeking donations. Depending on the situation, we may explore different monetization options for our Community and Expert Contributors. It's crucial to provide more returns for their expertise and offer more Expert Validated Answers or AI Validated Answers. Learn more about our hosting issue here.

What is eCTD?

April 26, 2017ectd

0

10 Posted

What is eCTD?

1 Answer

0

10 Posted

An eCTD is an electronic version of a CTD. The eCTD is comprised of various files and folders that together constitute a submission. Most of the documents in an eCTD containing submission text are provided in PDF (portable document format). Some other files may be in various formats to support data, programming and labeling (i.e., XML). Currently the FDA also requests that some sections be provided in Microsoft Word (.doc) format. In most cases, eCTD is the preferred method of submission for the FDA. Please see the FDAs eCTD webpage for additional information.