Pharmacoepidemiol Risk Manage.  2023 Sep;15(2):107-116. 10.56142/perm.23.0013.

Lessons from US FDA's COVID-19 Related Post-Marketing Drug Safety Monitoring and Evaluation Activities

• Lee HJ
• Lee JW
• Park SY
• Seong SH
• Jung SY

• KMID: 2551227
• DOI: http://doi.org/10.56142/perm.23.0013

Abstract

World Health Organization (WHO) has declared the termination of a public health emergency of international concern (PHEIC) about COVID-19 and regulatory authorities diminished the level of crisis response and transitioned into a longterm management system. The COVID-19 pandemic has had a significant impact on public health and healthcare infrastructure. In the early stages of the COVID-19 outbreak, there were no therapeutics or vaccines available. In response, expeditious development and dissemination of COVID-19 therapeutics and vaccines have been facilitated through processes such as prioritized examination and emergency use authorization (EUA). Consequently, the heightened emphasis on drug safety has prompted the U.S. Food and Drug Administration (FDA) to respond to the COVID-19 pandemic by implementing an information visualization platform to enable swift dissemination of safety information. Additionally, the FDA has undertaken research and safety measures, including the improvement of signal detection analysis and collaboration with international initiatives. In this review, we assessed the safety monitoring and evaluation system employed by the FDA for COVID-19-related therapeutics and vaccines, with the aim of providing pertinent information for the domestic drug safety management system in preparation for potential future outbreaks of novel infectious diseases.

Keyword

COVID-19; Food and Drug Administration; Post-marketing surveillance