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Regulatory Assessment
Definition 1
A regulatory action or inaction undertaken by the regulatory authority as a result of a submission analysis and evaluation. (NCI Thesaurus)
Definition 2
An evaluation of a submission by a regulatory body. EXAMPLE(S): An evaluation of a submission for a new drug or device that requires FDA approval. (NCI Thesaurus/BRIDG)
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A unique identifier assigned to a submitted application by the regulatory authority.
A coded value specifying the kind of regulatory application.
The primary category of an official application to the regulatory agency. It can cause specific types of regulatory requests. The type…
The date and time span for when the regulatory application sponsor is active.
The party who submits a marketing application to FDA for approval of a drug, device, or biologic product. An applicant is the…
A unique symbol that establishes identity of the regulatory application.
