Clinical trials utilize multiple methods of tracking, categorizing, and assessing any side effects at each trial stage. A negative side effect during clinical trials, whether expected as a potential ...

Since its creation in 1990, the U.S. Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) has provided publicly available data on any adverse reactions ...

Pregnant women with symptomatic coronavirus disease 2019 (Covid-19) have a higher risk of adverse outcomes than do women who are not pregnant. 1,2 In part because of these findings, Covid-19 ...

Immunotherapy enhances a patient’s immune system to fight disease and has recently been a source of promising new cancer treatments. Among the many immunotherapeutic strategies, immune checkpoint ...

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the ...

Discovery of immune checkpoint inhibitors has revolutionized the therapeutic landscape for the treatment of cancer. Development of immunotherapy for cancer is based on modulation of T cell function ...

Consolidation into AEMS removes fragmented querying across seven systems, improving accessibility of population-level safety signals relevant to pharmacovigilance and competitive intelligence.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is bringing sweeping changes to the cosmetics industry. One such change requires a “responsible person” to maintain and submit certain ...