Genomic epidemiology can provide insights into pathogen transmission and evolution—and facilitate better countermeasures against infectious disease.
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
Health inequities and disrupted STI testing and care during the pandemic continued to contribute to a rise in cases in 2021.
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
Group of 18 senators says ending Medicare coverage for at-home COVID-19 tests would undo efforts to contain spread of the coronavirus.