SafetyCall Publishes Methodology for a Standardized Approach to Adverse Event Data Analysis of Consumer Products

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

SafetyCall International’s, Dr. Rick Kingston, Speaks at DSQC Virtual Meeting

SafetyCall International’s President, Regulatory and Scientific Affairs & Sr. Clinical Toxicologist, Rick Kingston, recently spoke at the Dietary Supplements Quality Collaborative (DSQC) virtual meeting. DSQC’s membership is comprised of multi-stakeholders working to better the quality and safety of dietary supplements. They bring together members across all sectors to promote the safety of supplements. Their mission statement claims to “aim to …

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 …