I had to reschedule Biscuit’s latest message tonight in order to address a more pressing issue. Three days ago, I wrote about the FDA’s refusal to approve convalescent plasma infusions as a treatment for COVID-19. This afternoon, the FDA seemingly reversed itself and provided Emergency Use Approval (EUA) for using this approach to treat individuals acutelyContinue reading “Emerging news story: FDA reverses itself on plasma transfusions for COVID-19”
Category Archives: FDA
Hospitals do make mistakes, and you still can’t trust your COVID antibody test!
Two brief follow-ups before the weekend starts. First, an interesting op ed was published today in the New York Times (you might remember them from yesterday when I found fault with their declaration of “ 36,000 lost souls” based on an unreviewed computer projection). Today they did publish a very nice opinion piece by Dr. DanielleContinue reading “Hospitals do make mistakes, and you still can’t trust your COVID antibody test!”
FDA issues an alert about the Abbott ID NOW.
Today the FDA published an alert on the Abbott ID NOW COVID screening test. I refer you to my post on this issue from two days ago.
Flash; You may not want to be tested for COVID-19 using the Abbott ID NOW.
Today, a paper available online reinforced concerns that the Abbott ID NOW, a rapid molecular (genetic) detection test for COVID-19 viral RNA, is significantly less sensitive than traditional genetic assays employing the polymerize chain reaction. The major advantage for the Abbott test is that it is a small device that can be transported to testing sites andContinue reading “Flash; You may not want to be tested for COVID-19 using the Abbott ID NOW.”
The FDA puts the hammer down on unapproved blood tests – sort of.
The FDA today took action to clear up the mess in COVID-19 blood testing. You might remember that blood tests for COVID-19 were allowed to enter the US under a special emergency use approval (EUA) called Part D. Under this special exemption, a test could be imported and sold on a “promise” that the manufacturerContinue reading “The FDA puts the hammer down on unapproved blood tests – sort of.”
Truly Good News: FDA Approval for Remdesivir
The Food and Drug Administration announced Friday that it has provided Emergency Use Approval (EUA) for remdesivir in treating coronavirus patients who require hospitalization. With this approval, the drug is only available if administered intravenously, once a day for up to 10 days. No oral use of remdesivir has been tested or approved. EUA isContinue reading “Truly Good News: FDA Approval for Remdesivir”
Pandemic Pondering 