Could The Nightly Weather Report Help Rebuild Trust In The US FDA?
FDA officials joked about the possibility of having a regular TV segment to explain its activities, but Commissioner Califf believes the networks would not want it.
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Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax
US vaccine surveillance systems were triggered, but so far further investigation clears the bivalent COVID vaccine of any new safety concern. CDC and FDA’s attempt to control the narrative appears to have backfired, however, making what looks to be a non-issue more controversial than it needed to be due to limited public communication.
US FDA Mulls Granting Regulated Industry Flexibility To Respond To Misinformation
The rapid pace with which inaccurate information can spread on social media may necessitate loosening some of FDA’s regulations on sponsors to let them respond, Commissioner Robert Califf said at the J.P. Morgan Healthcare Conference. Califf also worried about how legitimate debate can undermine public confidence in FDA.
US FDA Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval
Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.