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Combatting Misinformation: FDA’s Califf On Use Of Facts, Opinion And Emotion

 
• By Brenda Sandburg

As discussion continues on the role of artificial intelligence in tackling misinformation and who gets to decide what information AI synthesizes, Califf and CBER’s Peter Marks call on clinical and biomedical community to dilute misinformation about vaccines with large amounts of scientific evidence.

Covid-19 misinformation
FDA is navigating how to counter misinformation and urging the biomedical community to promote scientific evidence on vaccines • Source: Shutterstock

The US Food and Drug Administration must be careful in its communications since an appeals court ruled it does not have the authority to endorse or denounce a medical practice. But agency officials say it is imperative to get accurate information through to the public.

“There's one strain of legal reasoning that a federal agency should just say the facts, and then it's up to others to decide what to do with those facts,” FDA Commissioner Robert Califf stated. Many of us “believe that if going beyond the facts goes too far, that's bad

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• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
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Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
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