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Supplemental Oncology Approvals: 'Reverse Accelerated Approval,' Not Lowering The Bar

 
• By Sue Sutter

Sometimes data supporting drug's initial approval can serve as confirmatory evidence for full approval of a subsequent indication based on an intermediate endpoint, US FDA Oncology Center of Excellence Director Pazdur says; proposed framework discussed at Friends of Cancer Research meeting would establish more systematic approach to streamlining supplemental approvals.

FDA entrance sign 2016

Granting regular approval to a supplemental oncology drug or biologic application based on an intermediate or surrogate endpoint can be a form of "reverse accelerated approval" and should not be seen as lowering the bar for demonstrating efficacy, the US FDA's top oncology drug official believes.

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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

 
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