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  • 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. OTHER NAME(S): NOTE(S): Over time, an application will typically consist of multiple submissions and regulatory assessments.
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Metadata

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