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Pink Sheet – Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors
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Endpoints News – When efficacy is borderline: FDA needs to get more consistent on close-call drug approvals, agency-funded research finds
News
The New England Journal of Medicine – Treatment of Older Adults with Cancer — Addressing Gaps in Evidence
News
Regulatory Focus – Groups suggest changes to FDA’s guidance expanding eligibility criteria for oncology trials
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OncLive – 3 Precision Era Biomarkers Get a Closer Look
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STAT News – Will controversy over new Alzheimer’s drug spell the end for the FDA’s faster approval process?
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Pink Sheet – FDA’s Pazdur Believes ‘Advanced Research’ Project Could Address Trial ‘Wastefulness’
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PharmExec.com – FDA’s Pazdur Challenges Attack on Accelerated Approval Program
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Regulatory Focus – Pazdur mounts defense of accelerated approval during Cures 2.0 panel
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Pink Sheet – FDA’s Pazdur: Accelerated Approval Is ‘Under Attack,' Supporters Can’t Afford To Remain Silent
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Bloomberg Law – FDA Cancer Head Defends Path Used for Biogen Alzheimer Approval
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Politico – Skeptics question if Biden’s new science agency is a breakthrough or more bureaucracy
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FierceBiotech – CRO ASCO and Friends push for more cancer patients in COVID-19 vaccine trials
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Bloomberg – Alzheimer’s Drug Discord Puts FDA Accelerated System Under Fire
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Adaptive Phage Therapeutics – Adaptive Phage Therapeutics Expands Board Following Series B Financing Led by Deerfield Management
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