In the past, sponsors submitting to FDA were required to submit a PDF describing their submission datasets. As we all know PDF is great for viewing on-screen or printing, but the information inside ...

Define-XML is the metadata that describes the content and formatting of submission datasets and the case report tabulation data. It’s needed to help reviewers understand the data they are reviewing.

XML refers to Extensible Markup Language, which is a language similar to HTML. If you have an XML document, you may be wondering how to open it. Although you can open an XML file in Notepad, the ...