FDA Evaluation of GMP Compliance during COVID-19 Pandemic

Summary

This article discusses how the ongoing novel coronavirus (COVID-19) pandemic has forced the U.S. Food and Drug Administration (FDA) to find innovative solutions to continue the agency's manufacturing facility inspection program. The agency is adapting by embracing new evaluation tools to assess compliance with current good manufacturing practice (cGMP) regulations by FDA-regulated companies. These evaluation tools are reshaping FDA's oversight and raising new considerations for companies facing FDA inspection.