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Food and Drug Administration and Compliance Issues
Saturday, February 29, 2020
Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics
Today, as part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.
“We believe this policy strikes the right balance during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”
There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China and which has now been detected in 50 locations internationally, including cases in the United States. The virus has been named “SARS-CoV2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). SARS-CoV-2 has demonstrated the capability to rapidly spread, leading to significant impact on health care systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the U.S. To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with ...