This definition of a" serious adverse event
" is limited.
The author reported total mortality, serious adverse events
(death, hospital admission, life-threatening events), and complicated ulcers for each study individually and a pooled estimate for both studies (median duration of 9 months).
22, 2007, all manufacturers, packers, and distributors of supplements will be required to report serious adverse events
to the FDA within 15 business days through the MedWatch program.
No serious adverse events
related to desloratadine syrup (0.5 mg/mL) were reported for any of the 255 infants and children, said Dr.
To characterize NVP-associated PEP toxicity, CDC and the Food and Drug Administration (FDA) reviewed MedWatch reports of serious adverse events
in persons taking NVP for PEP received by FDA (Figure 1).
Fifteen patients experienced serious adverse events
, including four cases of MAS (one with a lethal end), infections or flare-linked events.
"The intent and spirit of the Act is to require manufacturers to report to FDA the serious adverse events
that they receive, and to assure that consumers who want to contact the manufacturer have adequate information to do so," the association said.
Serious adverse events
that occurred in study participants included two perforations, and two intracerebral hemorrhages, including one that was a result of perforation, for a serious adverse event
rate of 3%.
First, it requires that the manufacturer, packer or distributor whose name appears on the product label (referred to as the "responsible person") report to FDA (using the agency's "MedWatch" form) any serious adverse event
associated with the product--serious is important for purposes of defining what types of events must be reported to the agency as opposed to the record keeping provisions--along with a copy of the product label within 15 business days of receiving the report.
14 September 2010 - US-based biopharmaceutical company Icagen Inc (NASDAQ: ICGN) announced yesterday that due to the occurrence of a serious adverse event
in the photosensitivity study of ICA-105665, it suspended further enrollment in the study.
So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses; the serious adverse event
reporting rate is 1.8 per 100,000 doses, based on VAERS data.
First, it requires that the manufacturer, packer, or distributor whose name appears on the product label (referred to as the "responsible person") report to FDA (on the agency's "MedWatch" form) any "serious adverse event
" associated with the product, along with a copy of the product label, within 15 business days of receiving the report.