Breaking FDA COVID-19 news

By Jenni Spinner

- Last updated on GMT

(ClaudioVentrella/iStock via Getty Images Plus)
(ClaudioVentrella/iStock via Getty Images Plus)

Related tags COVID-19 Coronavirus Fda Testing Fraud

The agency continues to take actions and issue advice related to COVID-19 treatments, tests, consumer products and other pressing industry concerns.

The US Food and Drug Administration (FDA) continues to be a source of information and advice for professionals in the life-sciences industry. The most recent activities coming from the agency include authorizations for tests, warnings of sketchy consumer products, and a controversial potential treatment.

Convalescent plasma

The agency has caused a stir by throwing its tentative support behind use of convalescent plasma as a COVID-19 treatment. As reported in​, earlier this week, commissioner Stephen Hahn FDA announced the agency was granting an emergency use authorization (EUA) for use of convalescent plasma in treating COVID-19 patients.

I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save live​,” Hahn said. “We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus​.”

Immediately the announcement was met with skepticism from certain corners of the pharma and medical communities. Walid Gellad, a scientist heading the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told the New York Times​ he questions the research and data associated shared by Hahn and other agency sources.

For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy​,” said Gellad. “That’s a problem if they’re starting to exaggerate data​.”

Hahn later apologized for misrepresenting findings around the benefits of convalescent therapy in COVID-19 treatment. "What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” he said in a statement​."

Test EUAs

The agency issued its third EUA for a COVID-19 antigen test.  The authorization was issued for LumiraDX UK’s LumiraDx SARS-CoV-2 Ag Test, for use in high and moderate complexity laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA), as well as at the point-of-care (i.e., patient care settings) operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

To date, the FDA has currently authorized 221 tests under EUAs. This figure includes include 179 molecular tests, 39 antibody tests, and 3 antigen tests.

Shady COVID-19 products

The FDA continues to monitor and warn companies making and selling products claimed to diagnose prevent, treat or cure the virus. To date, the agency has approved exactly zero consumer products for such use.

Companies and products receiving stern warnings from the FDA recently include:

  • SilveryGuy, an Amazon Associates participant, has been offering Colloidal Silver products on its website
  • Living Senior LLC has been selling cannabidiol (CBD) products purported to treat COVID-19
  • Predictive Biotech has been marketing CoreCyte, an umbilical cord-derived product, to treat the virus; PA Green Wellness received a separate warning for selling CoreCyte

Related news

Show more

Related products

show more

ODM and CDASH in CRF design

ODM and CDASH in CRF design

Formedix | 10-Mar-2023 | Technical / White Paper

The lesser-known Operational Data Model (ODM) standard is often overlooked as it's not required by any regulators. So, why should you be interested...

4 Warning Signs Your Research Site Is in Trouble

4 Warning Signs Your Research Site Is in Trouble

Elligo Health Research® | 10-Mar-2023 | Insight Guide

You want your clinical research practice to be a success for your business and your patients, but how can you tell if it’s in trouble? Read this article...

How Sponsors Reduce Chaos in Decentralized Trials

How Sponsors Reduce Chaos in Decentralized Trials

Florence Healthcare | 08-Mar-2023 | Insight Guide

89% of research sponsors currently use and expect to continue the use of decentralized technologies and methods, according to our state of the industry...

2023 State of Clinical Trial Technology Report

2023 State of Clinical Trial Technology Report

Florence Healthcare | 01-Mar-2023 | Insight Guide

Discover the trends shaping clinical trial technology in 2023, from Site Enablement to eISFs, integrations, and site-sponsor collaboration. This report...

Related suppliers

Follow us


View more