September 22, 2022
Life Sciences
  • 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)