WebApr 9, 2024 · The development safety update report (DSUR) proposed in this guidance is intended to be a common standard for periodic reporting on drugs under … WebCite. Data Lock-Point (cut-off date) means the date designated as the cut - off date for the data to be included in a periodic safety document such as PSUR, PADER or ASR / …
Guidance for Industry - Food and Drug Administration
WebAug 21, 2013 · The DSUR is the pre-marketing equivalent of the post-marketing Periodic Safety Update Report (PSUR). It covers drugs, biological, vaccines and combo products. It is a stand-alone document that is not just a data dump but is an analytical document. It should be “clear and succinct” (as all documents should be but rarely are). WebNov 1, 2014 · Periodicity and DSUR Data Lock Point DSUR should be submitted no later than 60 calendar days from DSUR data lock point Development International Birth Date (DIBD): Date of the sponsors first authorization to conduct a clinical trial in any country For administrative convenience, DIBD is the last day of MOA hutton wilkinson tony duquette
Periodic Safety Update Reports
WebNov 25, 2024 · The data lock point of the DSUR should be the last day of the one-year reporting period. For administrative convenience, if desired by the sponsor, the data lock point of the DSUR can be designated as the last day of the month prior to the month of the DIBD. The DSUR should be submitted to all concerned regulatory authorities no later … WebExamples of Data Lock Point for DSUR in a sentence. Any information on potentially important safety findings that arise after the Data Lock Point for DSUR while the DSUR … WebThe dates of a DSUR and PSUR submission can be synchronised by preparing a DSUR based on the PSUR international birthday (IBD). Then the data lock point of the DSUR, … hutton winches