The SafetyCall Blog

When a manufacturing deviation, product defect, or adverse event pattern raises questions about consumer or patient safety, companies need a structured, scientifically defensible way to assess the risk. A Health…

March 11, 2026  |  FDA Announcements, Adverse Event Reporting On March 11, 2026, the FDA officially launched the Adverse Event Monitoring System (AEMS), a unified platform designed to consolidate the…

The U.S. Food and Drug Administration (FDA) today published draft guidance clarifying its authority to access and copy cosmetic company records under the Modernization of Cosmetics Regulation Act of 2022…

SafetyCall International, the world's largest provider of adverse event management services for humans and animals, has been helping manufacturers navigate complex regulatory landscapes for over 20 years. As the only…

We are thrilled to announce that SafetyCall International has been recognized as a Minnesota Star Tribune Top Workplace for the 15th year! This recognition comes directly from our employees' feedback…

FDA released an updated guidance for industry to include instructions on mandatory adverse event reporting for cosmetics. Mandatory reporting was included in the sweeping legislative update for cosmetics last year,…

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the first major change to FDA’s cosmetics authorities since the passage of the Food, Drug, and Cosmetic Act in 1938.…

Presently, although there is no requirement for submitting individual adverse event human case reports involving food products to the FDA the Agency does have the expectation that manufacturers have a…

Last Wednesday, March 22nd, several members of SafetyCall’s regulatory team sat in on EPA and FDA’s Center for Veterinary Medicine (CVM) first joint public meeting in which they presented a…