The ID Pipeline: Plasma Authorization Paused, COVID-19 Saliva Test Gets EUA

A refresher on the week's developments in the infectious disease drug & medical device FDA approval pipeline.

Contagion offers daily coverage of developments in the infectious disease drug and medical device approval pipeline. Here’s some of what we reported on the past week:

FDA's COVID-19 Plasma Authorization On Hold, Still Possible

Convalescent plasma is donated by survivors of COVID-19. The treatment was found safe in recent studies, but as with many COVID-19 therapeutics the exact efficacy is still an open question.

The US FDA was said to be considering an emergency authorization for COVID-19 plasma just last week. For now, the authorization is being halted.

According to H. Clifford Lane, MD, the clinical director at the National Institute of Allergy and Infectious Diseases, the authorization is on hold while more data are reviewed.

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How to Read an FDA Emergency Use Authorization

Since the start of the COVID-19 pandemic, many diagnostics have been authorized by the US FDA. While releases tend to highlight the benefits an authorized company sees in the approval of a new test, they can be difficult to parse for information. Rodney E. Rohde, a clinical laboratory specialist at Texas State University, helps break down how carefully they must be read.

FDA Grants Emergency COVID-19 Authorization to Yale's Open Source Method of Saliva Testing

SalivaDirect does not require a particular type of swab or collection device; any sterile container is suitable for saliva collection with the test.

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