I'm a new contributor! I'll update my profile soon to include a little background information about myself.
I heard something that shocked me last week. With a wide-eyed look of horror slash fear slash dismay, an employee from a medium-sized biotech told me "Zach, I heard that if we are going to start submitting electronically, we need to learn XML." I actually haven't heard anyone say this since the dawn of eCTD adoption (years ago).
Who is still spreading this terrible rumor? You certainly don't need to go out and sign up for the next XML class at the local community college to prepare for your next submission. XML is the computer standard that is used to describe your submission to the reviewers. If you’re in the business of getting drugs approved, all you really need to learn about XML are some ideas specific to the eCTD XML standard, not the general rules of XML. The eCTD XML standard can be learned by attending eCTD conference sessions, training sessions, or by utilizing online resources like zenosis.com.


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