- The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report suggesting that the Food and Drug Administration’s (FDA) emergency use authorization (EUA) policies resulted in quality issues and false results with COVID-19 tests that quickly hit the market during the early stages of the pandemic. The OIG said the government should overhaul its EUA strategy before another pandemic occurs, advocating for a “coordinated federal effort to determine a federal testing strategy” that involves stakeholder feedback, improved communication practices with testing labs, more specific guidance on test validation, and additional FDA support throughout the process. (Article here)
September 22, 2022
Life Sciences