To date, there have been 15.3m confirmed COVID-19 instances world wide, with about 4m within the US alone. In response to the pandemic, the US Food and Drug Administration (FDA) continues to difficulty recommendation, hand out emergency use authorizations, launch steerage paperwork, and react to fraudulent merchandise.
EUA to Quest
The company this week reissued an emergency use authorization (EUA) to nationwide testing firm Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR take a look at. It is now approved to be used with pooled samples containing as much as 4 particular person upper-respiratory swab specimens collected underneath statement.
According to the company, the Quest Diagnostic take a look at is the primary COVID-19 diagnostic take a look at to be approved to be used with pooled samples.
Hotline goes chilly
On Friday July 17, the FDA shot down its COVID-19 Industry Hotline. The cellphone line was created to function a useful resource for life-sciences, pharmaceutical and medical professionals to acquire solutions to varied questions.
As an alternate, the company will present assist for builders, researchers, laboratories and different professionals on-line. The data will be discovered by way of the Contacts for Medical Devices During the COVID-19 Pandemic listing.
The company up to date its Frequently Asked Questions on Testing for SARS-CoV-2. The revised FAQs useful resource embrace an inventory of laboratories which were faraway from the listing of laboratories that had notified FDA that that they had developed and validated diagnostic checks as set forth in Section IV.A of the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).