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 …

Adverse Events 101

Rick Kingston, President, Regulatory and Scientific Affairs If you’re wondering exactly what constitutes an adverse event (AE), you’ve come to the right place. In general terms, an adverse event is an experience associated with the use of a product that is or could be considered adverse or unwanted. They typically fall into three categories: Toxicology-related adverse events – When humans …

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 …

Dr. Kingston Speaking at CSPA Annual Meeting

Dr. Rick Kingston will be speaking at the CSPA Annual Meeting in Ft. Lauderdale, FL.  This year’s Annual Meeting will offer guidance on what new federal environmental legislation will mean for your company.  Dr. Kingston’s presentation is on EPA Adverse Event Reporting: Past, Present and Future. Fore more information about the Annual Meeting, head to the CSPA website.

Dr. Kingston Speaking at CPSC From A-Z and Beyond

Dr. Rick Kingston will be speaking at the Consumer Product Safety Commission (CPSC) From A-Z… and Beyond, a full day conference in Washington, DC providing participants with a thorough understanding of the regulations administered by the US CPSC. Dr. Kingston is speaking from 10:45-11:30 on Post-Market Surveillance.  His presentation will cover: Data used by CPSC in regulatory process NEISS Data …

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 …

Adverse Event Management Services for Dietary Supplement Companies

By Rick Kingston, President, Regulatory and Scientific Affairs In recent years, the FDA has increased inspections of dietary supplement companies regarding good manufacturing practices (GMPs), which include the processes, procedures and documentation that ensure the product is indeed what appears on the label. During the inspection process, the company’s adverse event documentation and serious adverse event reporting systems (SAERs), or …

CRN Presents Free Webinar on Supplement Safety

Dr. Rick Kington will be the featured presenter during a free webinar for pharmacists and nurse practitioners (NPs) on dietary supplements and adverse event reporting results.  The webinar is sponsored by The Council for Responsible Nutrition (CRN) and will take place on Thursday, March 3, at 1:00pm Eastern.  The webinar is presented exclusively to members of Skipta’s Pharmacist Society and …