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References in periodicals archive ?
The agency opines that the blind should be broken for serious and unexpected adverse events that would meet the reporting criteria, either as single or multiple occurrences, because knowledge of treatment assignment may be essential for medical management of the subject, and may provide safety information having implications for the conduct of the trial.
In addition, under the new legislation, the voluntary registration programs for facilities and products would become mandatory, as would the reporting of any serious and unexpected adverse events.
The agency views Diagnostic Imaging's financial profile as highly leveraged, mainly due to its "insufficient liquidity for unexpected adverse events", despite the positive free cash flow of the past years.
Serious or unexpected adverse events associated with bisphosphonates can be reported to the FDA's MedWatch program at 800-332-1088 MedWatch/report.htm.
Serious or unexpected adverse events associated with these drugs can be reported to the FDA's MedWatch program at 800-332-1088 or
Simply put, an HRO promotes swift rebound rates that contain unexpected adverse events in a time-critical manner, all to avoid catastrophes.
There were no lingering or unexpected adverse events; between 1 week and 1 year post treatment, there were three respiratory-related hospitalizations in each study arm.
Additional education includes quarterly staff newsletter highlighting safety concerns, feedback to safety alerts, summary of unexpected adverse events and recommendations from the Safety Committee.
No significant new or unexpected adverse events were seen in the SXB-15 trial.
To monitor the occurrence of adverse events associated with vaccination, both those expected on the basis of previous experience and possible new unexpected adverse events, CDC and state health departments have established the Smallpox Vaccine Adverse Events Monitoring and Response System.
Finally, the bill distinguishes between research with higher and lowers risks and stipulates stricter regulations for monitoring high-risk trials and reporting any unexpected adverse events.