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Accelerated Approvals Could Be Improved By Focusing On Benefit/Risk, Making Withdrawal Easier

 
• By Sue Sutter

Applying the expedited pathway in the context of a preliminary benefit/risk assessment, rather than focusing solely on predictive surrogate or intermediate clinical endpoints, would give the US FDA more flexibility, Friends of Cancer Research working group says in a new white paper.

the waiter cleaning the table in a outdoor cafe. He collects dirty dishes in a tray.
Giving US FDA the ability to easily clear the table of an accelerated approval drug that fails to confirm clinical benefit is proposed in a new white paper. • Source: Shutterstock

The US Food and Drug Administration’s accelerated approval program could be improved by reframing its focus on a drug’s benefit/risk profile rather than the effect on a surrogate endpoint.

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US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases

 
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Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

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EU Pharmacopoeia Adopts ‘Groundbreaking’ Cell Therapy Chapter, Seeks Feedback On Alternative Microbiological Tests

 
• By Neena Brizmohun

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