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As previously published and shared on Natural Products Insider.
In an effort to promote transparency, FDA improved access to adverse events reports (AERs) via an online database that provides a variety of information in a search-friendly format. Though the database is intended to be a tool, the type and breadth of information, along with how the information is presented, …
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 …
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 …
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:
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. 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. 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:
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 …
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 …
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 …
