Category Archives: Adverse Event Reporting SystemThe National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report adverse events (possible side effects) that occur following vaccination, so the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) established the Vaccine Adverse Event Reporting System (VAERS) in 1990. VAERS is a national passive reporting system that accepts reports from the public on adverse events associated with vaccines licensed in the United States.
Potential Signals of Serious Risks What is FDA posting? The following reports list any potential signals of serious risks/new safety information that were identified using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean that FDA has concluded that the drug has this listed risk. It [...]
Goal Is to Provide Signs of Possibility Of Adverse Effects By JARED A. FAVOLE WSJ.com, September 5, 2008 8:07 p.m. WASHINGTON — The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care [...]
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