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Missing Data: One Long-Term Lesson From US FDA Action On Hydroxychloroquine

 
• By Michael McCaughan

Politicization of COVID-19 treatments is one of the unexpected wrinkles amid an unprecedented pandemic. But one lesson from the hydroxychloroquine experience in the US is more typical if still troubling: almost no one followed the rules on reporting follow-up data.

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The US Food and Drug Administration’s handling of the authorization allowing emergency use of hydroxychloroquine and chloroquine for treatment of COVID-19 will inevitably be viewed as a test of the agency’s independence in the context of the Trump Administration.

The 15 June revocation of the EUA granted for the products will certainly weigh heavily in favor of FDA’s independence...

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• By Vibha Sharma

A new guideline finalized by the International Council of Harmonisation is expected to reshape how non-interventional drug safety studies use real-world data, bringing clarity, consistency, and global alignment.

Intercept Withdraws Ocaliva From US, The PBC Drug’s Last Market

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

 
• By Sue Sutter and Sarah Karlin-Smith

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

 
• By Sue Sutter

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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More Vaccines At Risk At Upcoming ACIP Meeting As New Panel Members Join

 
• By Sarah Karlin-Smith

The ACIP put hepatitis B and MMRV vaccines on its agenda, despite having no new reason to relitigate the products, worrying public health experts that more anti-vaccine moves are coming.

US FDA Complete Response Letters Raise Confirmatory Evidence Shortfalls

 
• By Sue Sutter

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.

Why ACIP Could Get Away With Unscientific Actions US FDA Cannot

 
• By Sarah Karlin-Smith

The CDC and its Advisory Committee on Immunization Practices reportedly are planning to make unsubstantiated claims about COVID-19 vaccine adverse events with little recourse for manufacturers and other stakeholders.