Lumi

By Dave Muoio 03:43 pm May 4, 2020
Following numerous reports of underperforming COVID-19 antibody tests, the FDA has raised the bar for these products in a revision to its emergency testing policy. As of today, commercial manufacturers that notify the agency of their intent to submit a test for Emergency Use Authorization are required to do so within 10 business days from the date of notification. Further, the FDA has recommended...