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Excuses, Excuses: How ‘Delayed’ Confirmatory Trials Are Explained By FDA

 
• By Michael McCaughan

US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.

Excuses magnifying glass
• Source: Alamy

During a Reagan-Udall Foundation meeting tied to the 30th anniversary of the US Food & Drug Administration’s Accelerated Approval pathway, earlier this month, agency officials came armed with data to help shape the narrative around the ongoing debate over potential reforms to the program.

The data help, in part, to counter the argument that there are countless products that gain approval using the accelerated...

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COVID-19 Vaccine Studies On Spike Protein, Coadministration Reflect New US FDA Paradigm

 
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CBER Director Vinay Prasad wants the American public’s concerns about a possible link between spike protein and post-vaccination syndrome answered, while also demanding larger immunogenicity studies and new pragmatic trials to support coadministration with other vaccines.

COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad

 
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The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.

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US FDA Complete Response Letters Raise Confirmatory Evidence Shortfalls

 
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The agency identified deficiencies in efficacy evidence intended to support results from a single adequate and well-controlled trial for orphan applications, including weaknesses in animal data and insufficient quantity and quality of biomarker data.