COVID-19 | FDAnews

HHS Requests Development Plans for COVID-19 Diagnostics

March 10, 2020

The agency is most interested in products that have progressed beyond non-clinical studies. Read More

Quest Launches COVID-19 Test Service

March 9, 2020

The new service will test respiratory specimens collected in hospitals and physician offices. Read More

Elitech Earns CE Mark for COVID-19 Diagnostic

March 5, 2020

The test kit confirms the quality of the extracted sample material. Read More

Coronavirus R&D Gets $3.1 Billion in Emergency Funding

March 5, 2020

The bill allocated approximately $500 million for procurement of masks, personal protective equipment, pharmaceuticals and other medical supplies. Read More

FDA Issues New Policy to Expedite Coronavirus Diagnostics

March 2, 2020

FDA Commissioner Stephen Hahn said the agency is “adapting to this dynamic and evolving situation.” Read More

No Device Shortages from COVID-19 Outbreak, FDA Says

February 28, 2020

FDA Commissioner Stephen Hahn said that several facilities have been adversely affected by the outbreak. Read More

Co-Diagnostics’ Coronavirus Test Earns CE Mark

February 25, 2020

“We believe Co-Diagnostics is the first U.S. company to receive a CE-marking for a coronavirus IVD,” the company’s CEO said. Read More

CDC Issues New Coronavirus Test Reagents

February 24, 2020

The CDC also reported increased demand for respirators and facemasks. Read More

Novacyt Nabs CE Mark for COVID-19 Diagnostic

February 19, 2020

The company previously launched a research-use-only test for the novel coronavirus on January 31. Read More

IMDRF Cancels Singapore Meetings Because of COVID-19 Outbreak

February 18, 2020

The number of confirmed cases of COVID-19 infection in Singapore was 77 as of February 17. Read More

Coronavirus Outbreak Threatens Supply Chain, Says Former FDA Commissioner

February 14, 2020

It may be harder to identify and mitigate potential shortages for devices, he said. Read More

COVID-19
RSS

HHS Requests Development Plans for COVID-19 Diagnostics

Quest Launches COVID-19 Test Service

Elitech Earns CE Mark for COVID-19 Diagnostic

Coronavirus R&D Gets $3.1 Billion in Emergency Funding

FDA Issues New Policy to Expedite Coronavirus Diagnostics

No Device Shortages from COVID-19 Outbreak, FDA Says

Co-Diagnostics’ Coronavirus Test Earns CE Mark

CDC Issues New Coronavirus Test Reagents

Novacyt Nabs CE Mark for COVID-19 Diagnostic

IMDRF Cancels Singapore Meetings Because of COVID-19 Outbreak

Coronavirus Outbreak Threatens Supply Chain, Says Former FDA Commissioner

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The Revised ICH E8: A Guide to New Clinical Trial Requirements

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