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Reviewable Unit
Definition 1
A predefined portion of an application that, by agreement between the applicant and the review division, can be submitted prior to submission of a complete application. (NCI Thesaurus)
Definition 2
A discrete portion of a submission which is used to receive agreement. Once agreement is reached on all units within the submission the submission can then be approved. EXAMPLE(S): In a Modular pre-marketing application (PMA) several modules will be sent to the Food & Drug Administration (FDA). Each module will be agreed upon independently of other modules. The FDA then approves the submission based on compilation of all of the modules. These modules are reviewable units. A veterinary medicine New Animal Drug Application (NADA) (marketing application) is constructed from the Investigational New Animal Drug Application (INADA). In the INADA process the sponsor creates reviewable units. These reviewable units are then compiled to be used as documentation for the marketing application. (NCI Thesaurus/BRIDG)
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