Legal Aspects of Adverse Event Reporting

By Rick Kingston, President, Regulatory and Scientific Affairs In addition to contributing to product safety, adverse event monitoring and post market product surveillance help reduce liability and risk for manufacturers and other stakeholders. In legal liability cases, manufacturers are held to a relatively high standard of care. So, when a manufacturer has a product issue and gets sued, one of …

Mandatory Adverse Event Reporting: What You Need to Know

By Rick Kingston, President, Regulatory and Scientific Affairs Most people are familiar with adverse event monitoring by the Food and Drug Administration (FDA), involving everything from dietary supplements to prescription drugs and medical devices. There are other agencies that require mandatory adverse event reporting, such as the Environmental Protection Agency (EPA) under the 6(a)(2) provision, and the Consumer Product Safety …