The U.S. FDA moved the goal posts for other companies with its expansion of the emergency use authorization for Helix Opco LLC’s COVID-19 test to include both unsupervised self-collection of samples and testing of asymptomatic individuals. The new indications promise to make the Helix test the preferred tool for schools, universities, and work settings by reducing costs and increasing flexibility.
With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products. That message was drummed home throughout the Oct. 22 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
The U.S. FDA’s device center has declared it will not review emergency use authorization (EUA) requests for lab-developed tests (LDTs) for the COVID-19 pandemic, but on the agency’s most recent town hall, on Oct. 14, FDA officials were uncertain as to whether labs should file those EUAs, leaving labs in a state of limbo yet again.
The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing.
With an ongoing phase II trial showing that a pair of its SARS-CoV-2 neutralizing antibodies has so far reduced viral load, symptoms and COVID-19-related hospitalization and ER visits, Eli Lilly and Co. has asked the FDA to consider an emergency use authorization (EUA) for one of the components, LY-CoV555.
Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine.
The COVID-19 pandemic has not run its course, but the U.S. FDA is already working on a plan for handling devices in the period after the public health emergency ends. Bill Maisel, chief medical officer at the FDA’s Center for Device and Radiological Health (CDRH), said the agency is thinking through what would have to appear in a guidance for a transition that may span a number of months, providing industry with some much-needed breathing room.
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Visby Medical Inc. emerged from stealth mode to secure emergency use authorization (EUA) from the U.S. FDA for its Personal PCR device for detection of COVID-19 infections. It is the first FDA-authorized portable device to use the polymerase chain reaction technology for COVID-19 testing. The San Jose, Calif.-based company was known as Click Diagnostics Inc. until March 2020.
Detectachem Inc. has scored an emergency use authorization (EUA) from the U.S. FDA to market a new molecular RNA test kit for SARS-CoV-2 that provides color-coded results in about 30 minutes.