Category: L

Lost to Follow Up

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

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Lifecycle Operations

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

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Leaf Title

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

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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

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Labeling Supplement

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

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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

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