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 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

EPA changes in pest management regulatory reporting programsIt 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

Image - SafetyCall for Adverse Event Management ServicesIn 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 …

Kelly Sioris – Mentor of the Year

A huge congratulations to SafetyCall’s Dr. Kelly Sioris on being recognized as the University of Minnesota College of Pharmacy Mentor of the Year for 2014!  Kelly was nominated by her students and was selected out of 450 other mentors to win the award.  According to the University’s website, the Mentor of the Year is an individual who has shown support …

Celebrate the Dietary Supplement Health and Education Act with CRN

The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, invites you to join a month-long celebration of the 20th anniversary of the Dietary Supplement Health and Education Act (DSHEA). The celebratory effort will make strong use of CRN’s online platforms throughout the month of October, and involve consumer education; recognition of …