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 …