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 …
SafetyCall Receives the Herbal Insight Award
SafetyCall International is honored to accept the American Herbal Products Association’s (AHPA) annual Herbal Insight award. The Herbal Insight is awarded to an industry organization that has contributed to the furthering of knowledge and understanding of botanicals and their uses in addition to making contributions to advancing the industry. In the announcement made earlier this week, AHPA shared, “SafetyCall …
SafetyCall International and Pet Poison Helpline Celebrate 15 Years
SafetyCall International (SCI) and Pet Poison Helpline (PPH) are turning fifteen this year! To mark this important milestone, we wanted to look back at what’s made our company so successful, as well as see what’s in store for the future.
While our company’s roots stretch all the way back to 1984, the SCI and PPH of today officially launched in …
Our Clients and their Customers can count on us to always be our best!
Annie Asplen, Paramedic, MS
Medical Writer, Regulatory Assistant, Senior Information Specialist
Some employees have been with SafetyCall for a decade or more. Some of us have bachelor’s degrees, master’s degrees, or doctorates. Some of us have taught university classes in public health, published papers on toxicology, or trained newly-hired employees. With that kind of experience, it would be easy to …
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 …
Webinar: Best Practices for Adverse Event Management and Reporting
On August 9, 2012, Rick Kingston, President, Regulatory and Scientific Affairs at SafetyCall International, will be presenting as a part of the SOCAP International Webinar Series. His presentation is titled, “Best Practices for Adverse Event Management and Reporting” and will cover:
- Potential implications of pending and newly-implemented changes to regulations over adverse event reporting requirements for consumer products.
- FDA’s new
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 …
Can Your Adverse Event Reporting Practices Affect Your Insurance Rates?
Rick Kingston recently spoke at the Consumer Healthcare Products Association’s Regulatory and Scientific Conference regarding Best Practices in Safety Surveillance. During his presentation, Rick explained how dietary supplement firms and manufacturers with best practices in place for adverse event reporting are most likely to receive the best insurance rates. Rick was quoted in “The Tan Sheet” Vol. 20, No. 22 …
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