" /> Regulatory Application - CISMeF





Preferred Label : Regulatory Application;

NCIt related terms : RegulatoryApplication; Application;

NCIt 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.;

Alternative definition : CDISC-GLOSS: Application made to a health authority to investigate, market, or license a new product or indication.; FDA: 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.; BRIDG 3.0.3: 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.; BRIDG 5.3: 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.;

Details


Keyword's position in hierarchy(ies) : arborescence

You can consult :


Nous contacter.
12/05/2024


[Home] [Top]

© Rouen University Hospital. Any partial or total use of this material must mention the source.