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Tuesday, 04/14/2020 6:32:15 PM

Tuesday, April 14, 2020 6:32:15 PM

Post# of 205107
https://www.fda.gov/news-events Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics
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https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics
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“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation. We are dedicating all available resources to expediting the review of medical products, including diagnostics, to prevent the spread of this outbreak.”

“We applaud the FDA’s approach to speed the path toward emergency use authorization for COVID-19 diagnostics. This step may reduce development costs, speed the process for availability at more testing sites, incentivize private development and, ultimately, help save lives,” said Rick Bright, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. “At BARDA, we are identifying industry partners to develop rapid diagnostics that can be used in commercial and hospital labs or even doctors’ offices so that medical professionals and their patients have the information they need to take action.”
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Everything above was copied directly off the FDA.GOV website. DOUGSTER
Correction to Post: Well, you can't sell test kits unless they