adverse event reports

adverse event reports

The trial investigator’s reports of all serious and adverse events, injury and deaths, which he or she is legally bound to give to the drug sponsor, the institutional review board and the FDA.
References in periodicals archive ?
Patient age was available for 13,553 adverse event reports, and patients aged 10-19 years accounted for 53% of the reports overall and 58% of completed suicides for which age was reported.
The study, published in the Journal of Adolescent Health, looked at adverse event reports between January 2004 and April 2015 in the FDA Adverse Event Reporting System on the food and dietary supplements database.
Food and Drug Administration's Center for Veterinary Medicine has made 30 years of adverse event reports (AERs) easily accessible.
Reporting rates for RZV were 136 per 100,000 doses distributed (all adverse event reports) and 4.0 per 100,000 (serious adverse event reports) versus 106 and 4.4, respectively, for ZVL (8).
In a statement to Bloomberg, Adamas Pharmaceuticals said: The FAERS "database houses adverse event reports submitted to the FDA by drug manufactures and healthcare professionals.
FDA is accepting online submission of voluntary and mandatory dietary supplement adverse event reports. The agency has implemented a secure capability in the interest of efficiency and as a convenience to dietary supplement manufacturers, packers and distributors, as well as the public at large.
The numbers of adverse event reports were calculated in five age groups: 0-1 month (neonates), 1-12 months (infants), 1-3 years (toddler), 3-6 years (pre-school) and 6-14 years (school going).
All adverse event reports must include the SFDA's "Medical Device Adverse Event Reporting Form."
Assistant Secretary of Defense for Health Affairs Jonathan Woodson asked the surgeons general of the military services to conduct a review of available scientific evidence and adverse event reports to better understand any potential relationship between DMAA and these events.
The following is a summary of selected serious adverse event reports that were submitted to VAERS between June 8, 2006 and May 31, 2010.
The FDA will regulate the design and manufacture of infusion pumps in the wake of thousands of adverse event reports, the agency announced.
Adverse event reports generally only represent from 1 percent to 10 percent of actual incidence, so the number of hypersensitivity reactions and deaths is likely significantly higher, the researchers said.

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