SafetyCall Weighs in on Statement from FDA Commissioner on Agency’s New Efforts to Strengthen Regulation of Dietary Supplements

Rick Kingston, PharmD
President, Regulatory and Scientific Affairs & Sr. Clinical Toxicologist 
Many SafetyCall clients that manufacturer and distribute dietary supplements have likely seen the recent press release by FDA Commissioner Dr. Scott Gottlieb.
One thing that is clear, the FDA plans to crack down on companies that intentionally adulterate their products with unapproved ingredients. These companies put responsible manufacturers …

Quality Control

Annie Asplen, Paramedic, MS
Medical Writer, Regulatory Assistant, Senior Information Specialist

Most of our work is done independently, with team members helping callers one-on-one. Because of this, it can be difficult for our agents to assess the quality of their own work, which is vital to continued improvement. That’s why our quality control (QC) program is in place to help …

SafetyCall International Announces Employee Achievements

It is a great honor to announce that five veterinarians at SafetyCall recently passed the toxicology board-certification exam given by the American Board of Toxicology (ABT). We recognize the hard work and dedication needed to undertake this rigorous exam and are proud to count these newly minted toxicologists among the team at SafetyCall. Our newest diplomats of the ABT are …

Case Studies

Annie Asplen, Paramedic, MS
Medical Writer, Regulatory Assistant, Senior Information Specialist

Some of the case scenarios that we handle at SafetyCall are very common. Whether it’s a dog who chewed on a roach motel or a child who ate too many gummy vitamins, we sometimes get so practiced at handling similar calls that we could recite them from beginning to …

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 …

Quality Isn’t Just a Word at SafetyCall

Annie Asplen, Paramedic, MS
Medical Writer, Regulatory Assistant, Senior Information Specialist

At SafetyCall, we realize that the quality of our work can mean the difference between success and failure for our clients. For our callers, it can mean even more, since our first aid recommendations often determine how potentially dangerous chemical exposures are handled. To say that we take this …

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 …

Which Adverse Events need to be documented in a Validated Database?

Ryan Seaverson
Quality Assurance & Regulatory Manager

Many of our clients at SafetyCall market products that are regulated by the FDA, which makes the companies subject to numerous record keeping requirements, including the documentation of adverse events. The FDA defines the term “adverse event” as any health-related event associated with the use of a FDA regulated product that is adverse. …

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 …

Surveillance of Adverse Events for Dietary Supplements

It’s been 10 years since mandatory adverse event reporting (AER) for dietary supplements and OTC drugs has been in place.  During that time there has been an evolution of systems and processes associated with AERs.  The focus has shifted from manufacturers simply meeting the letter of the law and filing Serious AEs with the FDA to them being held accountable …