During the 11th hour of 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MOCRA) as part of the Consolidated Appropriations Act. SafetyCall has been closely monitoring the proposed cosmetic legislation for several years and, as anticipated, the MOCRA of 2022 establishes new regulations related to monitoring adverse events and mandatory reporting of all …
Summary of adverse drug events for hydroxychloroquine, azithromycin, and chloroquine during the COVID-19 pandemic
Dauner DG, Dauner KN. J Am Pharm Assoc (2003). 2021 May-Jun;61(3):293-298.
The United States declared a national emergency concerning the coronavirus disease 2019 (COVID-19) outbreak on March 13, 2020, and on March 28, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the use of oral formulations of hydroxychloroquine (HCQ) and chloroquine (CQ) in …
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 …
Adverse Event Best Practices for Businesses Engaged in Social Media
Rick Kingston
President, Regulatory and Scientific Affairs/Sr. Clinical Toxicologist
It’s been more than a decade since Facebook and Twitter launched in the mid-2000s. At the time, we couldn’t have predicted the sphere of influence social media would have on society – and our businesses.
For most companies, social media has become a managed function alongside more traditional marketing functions like …
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
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.…
Adverse Event Reporting Webinar
Title: The Importance of a Robust Adverse Event Reporting System
Date: Wednesday, October 29, 2014
Time: 2:00 PM Eastern / 11:00 AM Pacific Time
The What, When, Why and How of Serious Adverse Event Reporting
Serious Adverse Event Reports (SAERs) should be a major concern for dietary supplement companies as adverse events can happen at any time. SAER issues can …
Webinar: The Buzz on Caffeine
Dr. Kingston will join a group of faculty to present a two hour webinar hosted by the Institute of Food Technologists.
“The Buzz on Caffeine: New Developments in Safety, Regulation and Adverse Event Reporting”
Caffeine, a methylated xanthine, is the most widely used mild central nervous system stimulant, naturally present in many common conventional foods and dietary supplements. More …
Adverse Event Reports on the Rise – Is there a Safety Issue?
Does FDA’s expectation of increased serious adverse event reports involving dietary supplements signal a safety issue with these products?
In recent months, the U.S. Food and Drug Administration (FDA) has been advising dietary supplement companies to review their SOPs regarding adverse event documentation and reporting of serious adverse events to the FDA. FDA believes that there are good indications that …
Welcome to the SafetyCall Blog!
Today SafetyCall enters the blogosphere with the launch of our blog site. Staying true to SafetyCall’s mission of communicating clear and trusted health, safety, and medical information 24/7, the content of our blogs will reflect just that, information and opinions from health care practitioners with a specialized yet broad area of knowledge. That knowledge relates to a clear understanding of …