Analyzing the Evidence For The Convalescent Plasma EUA

The justification President Trump used is not directly mentioned in the decision memo, but other data suggests a less-than-overwhelming case for granting emergency use authorization.

Antibodies immunoglobulins attacking coronavirus covid-19 influenza virus cell, 3D immune system medical illustration background. Corona virus 2019-ncov sars cell, igm. Coronavirus sars-cov-2 disease
The FDA used several kinds of evidence to make its decision on the convalescent plasma EUA. • Source: Shutterstock

US Food and Drug Administration officials agreed there is enough evidence that convalescent plasma “may be effective” and warranted an emergency use authorization, but argued more definitive data is necessary to pinpoint efficacy and the optimal populations that could benefit.

More from Product Reviews

More from Pink Sheet

Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By 

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says

 
• By 

The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.