Intellectual Product
regulatory report
reg·u·la·to·ry re·port
Definitions related to regulatory report:
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(report) A submission that contains a new annual report, Periodic Adverse Drug Experience Report (PADER) or Periodic Safety Update Report (PSUR).U.S. FDA GlossaryU.S. Food & Drug Administration, 2021
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A collection of reports filed with regulatory authorities across the conduct of a trial; including but not limited to Periodic Reports, Interim Reports, and Annual Reports.Content Archive Resource Exchange LexiconCareLex, 2013
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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.BRIDG Model DictionaryBiomedical Research Integrated Domain Group, 2019
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A type of report required by a regulatory agency.NCI ThesaurusU.S. National Cancer Institute, 2021
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