CDRH
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.
At an industry conference last week, a scientific reviewer at FDA's Office of In Vitro Diagnostics Device Evaluation and Safety discussed detailed strategies for navigating the regulatory process for Rx/Dx combination products.
Two FDA officials last week highlighted the agency's ongoing efforts to personalize healthcare by improving internal expertise in pharmacogenetics, increasing its focus on regulatory science, and launching a new group to coordinate its drug and diagnostics divisions’ application reviews for Rx/Dx combination products.