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 …
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 Aids Clients with Amazon Disputes
Recently, we’ve been contacted by clients that have had their products pulled from Amazon after individual consumers have posted unsubstantiated allegations that their product caused them to become ill. In some cases, consumers have indicated in their product review that they needed to go to the ER but provided little detail regarding any diagnosis and/or treatment information and whether or …
For SafetyCall Clients, Our Expertise is Peace of Mind
At SafetyCall, our clients often tell us we bring them “peace of mind.” We love to hear that, since our mission is to make the world a safer place by assuring and providing quality care for our clients and their customers. The customer piece is especially important to our clients, and it’s where our Call Center shines.
SafetyCall health …
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 …
Webinar: CCPSA to be Offered by SafetyCall
A webinar designed to help manufacturers understand and prepare for the ramifications of the new Canada Consumer Product Safety Act (CCPSA) will be presented at 12:00 p.m. CDT on September 14, 2011, by SafetyCall International, an industry leader in adverse event management and post-market surveillance services for industry.
The webinar, “How the Canadian Consumer Product Safety Act WILL Affect Your …
Canada Consumer Product Safety Act (CCPSA) Goes Live
On June 20, 2011, the Canada Consumer Product Safety Act (CCPSA) came into force requiring industry to provide information to the Minister of Health regarding the occurrence of an incident that resulted or could reasonably be expected to have resulted in death or serious adverse health effects. Such incidents are also not limited to just Canada if a Canadian product …