This week’s FDA COVID-19 updates
To date, there have been 15.3m confirmed COVID-19 cases around the world, with about 4m in the US alone. In response to the pandemic, the US Food and Drug Administration (FDA) continues to issue advice, hand out emergency use authorizations, release guidance documents, and react to fraudulent products.
EUA to Quest
The agency this week reissued an emergency use authorization (EUA) to national testing company Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test. It is now authorized for use with pooled samples containing up to four individual upper-respiratory swab specimens collected under observation.
According to the agency, the Quest Diagnostic test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.
Hotline goes cold
On Friday July 17, the FDA shot down its COVID-19 Industry Hotline. The phone line was created to serve as a resource for life-sciences, pharmaceutical and medical professionals to obtain answers to various questions.
As an alternative, the agency will provide support for developers, researchers, laboratories and other professionals online. The information can be found through the Contacts for Medical Devices During the COVID-19 Pandemic directory.
The agency updated its Frequently Asked Questions on Testing for SARS-CoV-2. The revised FAQs resource include a list of laboratories that have been removed from the list of laboratories that had notified FDA that they had developed and validated diagnostic tests as set forth in Section IV.A of the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
According to the FDA, the laboratories taken off the list were removed because the agency determined there are significant problems with the associated tests that cannot be, or have not been, addressed in a timely manner and should no longer be used.
Guiding against fraud
In a recently issued document in the FDA Voices series, titled FDA Protects Patients and Consumers from Fraud During COVID-19, FDA representatives explain the agency’s work to prevent fraudulent preventive or curative products from reaching consumers’ hands. To date, the FDA has not approved any such products to treat the virus.