Healthcare professionals, toxicologists and other scientists at SafetyCall International have been managing product related adverse events on behalf of manufacturers for decades. During this time SafetyCall has managed more than 3,000,000 incidents and helped manufacturers with early detection of safety issues and implement strategies to manage and mitigate adverse events. SafetyCall’s experience and methodology in this important area has recently …
FDA Now Making Data Available from CFSAN’s Adverse Event Reporting System (CAERS)
As part of the FDA’s commitment to transparency, for the first time it has begun posting data from CFSAN’s Adverse Event Reporting System (CAERS) on FDA.gov here and through OpenFDA. It’s downloadable in ASCII format, which is amenable to automated querying.
The database contains information on adverse event and product complaint reports submitted to the FDA for Center for Food …
Changes Coming to the EPA’s Adverse Event Reporting System
By Rick Kingston, President, Regulatory and Scientific Affairs
It has been a number of years since there has been any change to the EPA’s adverse event reporting systems. The last major change came in with passage of the 6(a)(2) provision in 1997, which set forth requirements for reporting of adverse events involving EPA registered products. EPA subsequently put out PR …