Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help?utm_campaign=031620_Statement_FDA%20Provides%20More%20Regulatory%20Relief%20During%20Outbreak&utm_medium=email&utm_source=Eloqua

Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics

This statement is attributed to: FDA Commissioner Stephen M. Hahn, M.D.

Today, as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today’s updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories.  This action demonstrates the FDA’s ability to pivot and adapt as the situation warrants in light of a public health emergency. We are taking steps to support diagnostic development considering the urgent need. We urge state authorities and commercial developers to...

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