<n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>The submission that represent the application's primary supportive material. There should only be one submission with a sub-type of application within a given submission-group.</n0:def-definition><n0:def-source>FDA</n0:def-source><n0:attr>eCTD</n0:attr> </n0:ComplexDefinition><n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance. EXAMPLE(S): The marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action.</n0:def-definition><n0:def-source>BRIDG</n0:def-source></n0:ComplexDefinition>
<n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>A collection of submissions related to a particular regulated product that are grouped together for regulatory purposes and can be referenced in making one or more regulatory decisions.</n0:def-definition><n0:def-source>NCI</n0:def-source></n0:ComplexDefinition>