Overall Goal

Determine the toxicity from therapeutics used to treat COVID-19, focusing on monoclonal antibodies.


The FDA contracted ACMT, the American College of Medical Toxicology, to identify adverse events from therapeutics used to treat COVID-19. In the 2020-2021 fiscal year the FDA was interested in any therapeutic, including, for example, dexamethasone. In the 2021-2022 fiscal year, the FDA focused on monoclonal antibodies and vaccines.

What is an Adverse Event?