About: Regulatory Application

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An Entity of Type : owl:Class, within Data Space : linked.opendata.cz associated with source document(s)

Attributes	Values
rdf:type	Class
rdfs:label	Regulatory Application
rdfs:subClassOf	Application Food, Drugs, and Medical Devices Regulatory Document
Concept_In_Subset	FDA eCTD Terminology eCTD Submission Sub-Type Terminology
Semantic_Type	Intellectual Product
Preferred_Name	Regulatory Application
UMLS_CUI	C2347934
Contributing_Source	BRIDG FDA
ALT_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.BRIDG 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.FDAeCTD
Legacy_Concept_Name	Regulatory_Application
FULL_SYN	ApplicationSYNCI Regulatory ApplicationPTNCI ApplicationPTFDA RegulatoryApplicationPTBRIDG
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.NCI
code	C70868
is rdfs:subClassOf of	New Device Application (CDRH) Product Development Protocol Premarket Approval Application Emergency Use Authorization Safety Issue Application

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