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Missing Data Hinders Inclusion Of Patient Experience In Drug Labeling, US FDA Says

 
• By Brenda Sandburg

Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.

Patient data
Missing data on trial endpoints can limit drug label claims • Source: Shutterstock

One of the challenges US Food and Drug Administration reviewers face is missing data in sponsor applications, particularly data on trial endpoints needed for a labeling claim.

FDA’s Michelle Campbell, senior clinical analyst for stakeholder engagement and clinical outcomes in the Office of Neuroscience, highlighted this problem during a 25 July FDA webinar on patient-focused drug development

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Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
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US FDA Restoring Some Library Resources

 
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US FDA Advisory Committee Misperceptions Abound … At HHS

 
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HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
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The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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