Sadr

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n.1.(Bot.) A plant of the genus Ziziphus (Z. lotus); - so called by the Arabs of Barbary, who use its berries for food. See Lotus (b).
References in periodicals archive ?
One hour to assemble and submit any follow up reports of new medical information regarding the serious adverse event report, as recommended in the guidance;
ATLANTA -- Postlicensure safety data from the first year of widespread use of Gardasil show that serious adverse events from the quadrivalent human papillomavirus vaccine are rare.
The newly enacted Dietary Supplement and Nonprescription Drug Consumer Protection Act mandates for the first time the reporting of serious adverse events associated with dietary supplements and over-the-counter products.
Although the most significant increase in 2004 post-marketing reporting was for serious adverse events reported periodically, reports directly from individuals increased by 6%, expedited reports increased by 12% and non-serious periodic reports increased by 3%, Berry noted.
Serious adverse event reporting is mandatory for dietary supplement pursuant to the Dietary Supplement and Nonprescription Drug Consumer Protection Act, enacted in December 2006.
Serious adverse events are defined as those that result in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, or a congenital abnormality or birth defect; or that require, based on reasonable medical judgment, a medical or surgical intervention to prevent one of these outcomes.
The serious adverse event occurred in the 600 mg patient cohort following completion of the 500 mg patient cohort.
While not included in the language of the Act as passed, the Senate HELP Committee stated that when a report is received from a consumer who believes that he or she has experienced a serious adverse event consistent with the factors listed above, it is the responsibility of the entity taking the report to forward the report to FDA regardless of whether or not the reporting consumer sought medical care or otherwise had proof of a serious adverse event.
They had 24 serious adverse events, including two drug-related serious adverse events.
While not included in the language of the Act as passed, the Senate HELP (Health, Education, Labor, and Pensions) Committee stated that when a report is received from a consumer who believes that he or she has experienced a serious adverse event consistent with the factors listed above, it is the responsibility of the entity taking the report to forward the report to FDA whether or not the reporting consumer sought medical care or otherwise had proof of a serious adverse event.
When the Dietary Supplement and Nonprescription Drug Consumer Protection Act goes into effect in December 2007, dietary supplement and OTC drug companies will be required to submit serious adverse event reports (AERs) to the FDA so that any public safety concerns can be identified and dealt with quickly.
With this law, consumers can be assured that if they report to a manufacturer a serious adverse event they believe may be associated with a supplement product, that the agency that regulates this industry--FDA--will be made aware of that report.