A recent FierceBiotech article discussed the FDA’s action to remove coronavirus antibody tests from the market. The agency ended its open-door policy on blood tests and now requires developers to submit their products and data for review. In total, the FDA is asking that 28 serology tests be pulled from the market including tests that were voluntarily withdrawn by their sponsors and others that never pursued official FDA Emergency Use Authorization. Test makers with active products were given 10 days to submit applications for review.
Quick Hits: FDA Cracks Down on Antibody Tests
The FDA listed 28 coronavirus antibody diagnostic tests that should be removed from the market.
May 28, 2020