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Analyzing the Evidence For The Convalescent Plasma EUA

 
• By Derrick Gingery

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.

In a clinical memo, agency officials outlined the different and sometimes conflicting evidence that fed into its decision to...

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There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

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• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

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US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
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Recent And Upcoming FDA Advisory Committee Meetings

 
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