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PSUR
(redirected from Periodic Safety Update Report)

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AcronymDefinition
PSURPeriodic Safety Update Report
PSURPesticide Sales and Use Reporting (New York)
PSURPennsylvania State University Reactor
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Once a medical device is on the market, manufacturers must continue to submit periodic safety update reports (PSURs) to the CLAA.
Updates on medical device regulations in India by Gross, Ames; Hirose, Momoko / Medical Product Outsourcing
In addition, the Periodic Safety Update Report (PSUR) format may also change significantly to require scientific evaluation of risk benefit balance, and would contain summaries of data relevant to risk benefit.
Change as constant: why pharma companies should act now in ... by Pharma
The program involves review of adverse events, data mining analyses, epidemiological data, postmarketing clinical trial data and periodic safety update reports to identify safety concerns for selected new molecular entities 18 months after approval.
FDA piloting safety studies of NMEs, revamping AERS, based on IOM ... by Mashaw, Rebecca / Adverse Event Reporting News
 
 
 
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