About the Project

The rapid spread of COVID-19 has posed an unprecedented challenge to healthcare providers and the public health community. The COVID-19 pandemic has an immense societal impact and has called for an all-out public health response. There is an urgent need for rapid data collection and dissemination of medical information associated with COVID-19 to the medical and public health community, including treatments to combat the disease.

Treatment for COVID-19 has included both the new use of established medications and the emergence of novel therapeutics. The advancing knowledge of COVID-19 mechanisms has led to a rapid pace of evolving treatment methods with very little prior scientific evidence or proven dosing regimens. The risk of increased adverse drug events (ADEs) is evident, and there is a need for enhanced monitoring.

Safety surveillance of adverse events specific for drugs and substances associated with the treatment of patients with COVID-19 is consistent with FDA’s mission of ensuring drug safety throughout the drug lifecycle. The FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project Sub-registry provides a mechanism for enhanced collection of safety data related to drug therapies used in patients treated for COVID-19.

Funding for this initiative was made possible through a contract from the FDA (Contract#: 75F40119D10031). The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the FDA; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

Principal Investigators

Co-Investigator:
Jeffrey Brent, MD, FACMT
University of Colorado School of Medicine
Aurora, CO 

Co-Investigator:
Paul Wax, MD, FACMT

Project Site Location Map