Regulatory Application

Definition 1

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. (NCI Thesaurus)

Definition 2

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. (NCI Thesaurus/BRIDG)

Definition 3

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. (Food and Drug Administration)

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Regulatory Affairs

The business of a regulatory agency.

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