FDA expedites review of diagnostic tests to combat COVID-19
April 2, 2020
A statement from Stephen M. Hahn M.D., Commissioner of Food and Drugs - Food and Drug Administration
The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests...