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US FDA Argues Very Few Accelerated Approvals Remain On Market Without Confirmation

 
• By Michael McCaughan

Of products that have had accelerated approval for at least a decade, just 6% are still marketed without the promised confirmatory evidence. And those include cases like ‘antibiotics approved for inhalational anthrax, where the lack of confirmatory clinical trial is a good thing.’ FDA’s Corrigan-Curay says.

Pill with security shield
FDA's defense of the current accelerated approval system is revealing itself. • Source: Shutterstock

The US Food & Drug Administration is set to defend the timeliness of Accelerated Approval confirmatory trial conduct with data as it heads into a period of legislative attention to ideas to improve the pathway.

Center for Drug Evaluation & Research Principal Deputy Director Jacqueline Corrigan-Curay led a trio of FDA officials in presenting an...

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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
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US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
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Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
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US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
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Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
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