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Regulatory Report
Definition 1
A type of report required by a regulatory agency. (NCI Thesaurus)
Definition 2
A report that provides notification of an adverse event, product problem, and/or information that is relevant to either. A report typically includes causal association, management strategies, authorship, sender/receiver organizations, subject of adverse event, or name of product. EXAMPLE(S): An Expedited AE report - a report of a serious and unexpected adverse event that must be submitted within specific timeframes to the sponsor and regulatory agencies. (NCI Thesaurus/BRIDG)
Definition 3
A submission that contains a new annual report, Periodic Adverse Drug Experience Report (PADER) or Periodic Safety Update Report (PSUR). (Food and Drug Administration)
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Encoded by Regulatory Genes, Regulatory Proteins regulate or circumscribe the activity of many cellular functions.
A process that acts to control the rate or manner in which another process progresses or a product is formed.
An elaboration of the known or inferred interactions controlling the expression of a product.
