The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject. Source: FDA Glossary

The operation attribute gives the status of the new file (where applicable) in relation to what has been submitted previously, and it has the following

The eCTD content is made up of multiple files. The eCTD contains a “”” element for each of these files. The leaf title is used

File referenced by the eCTD XML backbone.

All written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment

According to the FDA, a Labeling Supplement is a supplement to an approved application that contains labeling changes only. Source: SOPP 8401.2: Administrative Processing of

Display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed