Adverse Event Reporting (AER) has been a requirement for dietary supplement manufacturers, packers and distributers in the United States since December 22, 2007. Companies are required under the Dietary Supplement and Nonprescription Drug Consumer Protection Act to report all serious adverse events (SAEs) to the FDA. Many companies do not have the in-house expertise to complete AERs and may not keep appropriate records for dietary supplements and non-prescription drugs to fulfill this obligation. dicentra has both the scientific and regulatory expertise to assist you in this area.
You can minimize your legal risks by having dicentra handle your Adverse Event Reporting.