CDRH
Review of FDA COVID-19 EUA Process Finds Issues With IT, Staffing, Validation Frameworks
In an independent review, a contractor evaluated the agency's response to the COVID-19 pandemic and provided recommendations for improvement.
FDA Provides Guidance on Pooled Samples, Asymptomatic Testing for SARS-CoV-2
The move is intended to increase testing for COVID-19 and may help conserve resources, which were a major problem during the height of the pandemic.
Faced With Confusion, Questionable Claims, FDA Addresses Coronavirus Serology Testing
Representatives spoke to serology test accuracy, CLIA categorization of tests, and new sample types, among other issues.